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Accord Healthcare, Inc. FDA Recalls
104 recalls on file across drugs, 1 of them Class I and 25 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, IncClass IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-cClass IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-counClass IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, IClass IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare,Class IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-couClass IIAug 6, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 300 mcg (0.3mg), 90 Tablets bottles, Rx only, Manufactured for: Accord Healthcare, InClass IIJun 8, 2026Subpotent Drug |
| Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 90 Tablets per bottle, Rx Only, Manufactured for Accord HealthcareClass IISep 16, 2025Subpotent: During long term stability testing of Levothyroxi |
| Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, IClass IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc.Class IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, IClass IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, InClass IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Only, Manufactured for: Accord Healthcare, IncClass IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, Class IIJun 20, 2025Subpotent Drug: Assay below the approved specification |
| Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 90 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., RaClass IIApr 10, 2025Subpotent |
| Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., RaClass IIApr 10, 2025Subpotent |
| Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., RClass IIApr 10, 2025Subpotent |
| Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000 bottles, Rx Only, Manufactured for Accord Healthcare, Inc., RClass IIApr 10, 2025Subpotent |
| Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottle, Rx Only, Manufactured for: Accord Healthcare, IClass IINov 8, 2024Subpotent drug |
| Cinacalcet Tablets, 60 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-441-10, b) 90 Tablets per bottle, NDC: 16729-44Class IIOct 10, 2024CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Cinacalcet Tablets, 90 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-442-10, b) 90 Tablets per bottle, NDC: 16729-44Class IIOct 10, 2024CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Cinacalcet Tablets 30 mg, Rx Only, a) 30 Tablets per bottle, NDC: 16729-440-10, b) 90 Tablets per bottle, NDC: 16729-440Class IIOct 10, 2024CGMP Deviations: the presence of a nitrosamine impurity, N-n |
| Cisplatin Injection, 100mg/100mL (1mg/mL), For Intravenous Use, 100 mL Multiple Dose Vial, Rx Only, Manufactured for: AcClass IIOct 1, 2024Failed Impurities/Degradation Specifications. |
| Dodex Injectable (Cyanocobalamin Injection) USP, 1,000mcg/mL, 1mL multiple dose vial, Rx only, Manufactured for: Accord Class IIIJun 18, 2024Subpotent drug: out of specification results |
| Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: AClass IIJul 3, 2023Presence of Particulate Matter: Particulate matter identifie |
| Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27Class IIJul 3, 2023Presence of Particulate Matter: Particulate matter identifie |
| Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or SubcutanClass IIIMar 29, 2023Sub-potent drug: assay test result below specifications at 9 |
| Glimepiride Tablets USP, 2 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-002-01 UPC 3 16729 00201 1; b) 500 TabletsClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 20 mg Rx Only, packaged as, a) 30-count bottle, NDC 16729-282-10, UPC 3 16729 28210 9; b) 100Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Rosuvastatin Tablets, USP, 10 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-285-15, UPC 3 16729 28515 5; b) Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Rosuvastatin Tablets, USP, 5 mg*, Rx Only, Packaged as: a) 90-count bottle, NDC 16729-284-15, UPC 3 16729 28415 8; b) 1Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| BusPIRone Hydrochloride Tablets USP 15 mg, Rx Only, 100-count bottle, Manufactured for: Accord Healthcare, Inc., Durham,Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Dofetilide Capsules 500 mcg (0.5 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Vigabatrin for Oral Solution, USP, 500 mg, Rx Only, 50-packets/carton, Manufactured for: Accord Healthcare, Inc., DurhamClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord HealthcarClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Clopidogrel Tablets USP, 75 mg, Rx Only, Packaged in a) 30-count bottles NDC 16729-218-10 UPC 3 16729 21810 8; b) 90-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-counClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glycopyrrolate Injection, USP, 0.2 mg/mL, 1 mL Single Dose Vial x 25 vials, Rx Only, Manufactured for: Accord HealthcareClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Simvastatin Tablets USP 40 mg Rx Only, Packaged as: a) 90-count tablets NDC 16729-006-15, UPC 3 16729 00615 6; b) 1,000Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 30 mg Rx Only, a) 30-count bottle, NDC 16729-283-10, UPC 3 16729 28310 6; b) 100-count bottleClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pravastatin Sodium Tablets USP, 40 mg, Rx Only, 1,000-count bottle Manufactured for: Accord Healthcare, Inc., Durham, NCClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManuClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Finasteride Tablets USP, 5 mg, Rx Only, Packaged as: a) 30-count bottles NDC 16729-090-10 UPC 3 16729 09010 0; b) 90-couClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Doxazosin Tablets USP, 4 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-213-01 UPC 3 16729 21301 1; b) 1,000-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 0.5 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 MClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Finasteride Tablets USP, 1 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-089-10 UPC 3 16729 08910 4; b) 90-couClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Doxazosin Tablets USP 1 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-211-01 UPC 3 16729 21101 7; b) 1,000-couClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pravastatin Sodium Tablets USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-008-15, UPC 3 16729 00815 0; bClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pravastatin Sodium Tablets USP 20 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Rosuvastatin Tablets, USP 20 mg* Rx Only, Packaged as: a) 90-count bottle NDC 16729-286-15, UPC 3 16729 28615 2; b) 1,0Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare,Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Montelukast Sodium Tablets, USP, 10 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-119-10 UPC 3 16729 11910 8; bClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManuClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| BusPIRone Hydrochloride Tablets USP 7.5 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., DurhamClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pirfenidone Tablets 801 mg, Rx Only, 90-count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManufaClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 MaClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glimepiride Tablets USP, 1 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-001-01 UPC 3 16729 00101 4; b) 500-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Dofetilide Capsules 250 mcg (0.25 mg) 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 0.25 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Atorvastatin Calcium Tablets USP 80 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-047-15 UPC 3 16729 04715 9; b) 500 Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| BusPIRone Hydrochloride Tablets USP 30 mg, 60-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 10 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-280-10, UPC 3 16729 28010 5; b) 100-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| BusPIRone Hydrochloride Tablets USP, 10 mg 500-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham,Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 10 mL Multiple-dose vial in 10x10 carton, Rx Only, ManClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| rOPINIRole Tablets USP 1 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 ManClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord HealtClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Daptomycin for Injection 500 mg per vial, Single-dose vial, Rx only, Manufactured by: Intas Pharmaceuticals Limited, PhaClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glycopyrrolate Injection, USP 4 mg/20 mL (0.2 mg/mL) 20 mL Multiple Dose Vial, 10vial carton, Rx Only, Manufactured for:Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Simvastatin Tablets USP 5 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-156-15, UPC 3 16729 15615 8; b) 1,000-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Atorvastatin Calcium Tablets USP 20 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-045-15 UPC 3 16729 04515 5; b) 1,0Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Simvastatin Tablets, USP, 10 mg, Rx Only, Packaged as: a) 90-count bottle NDC 16729-004-15, UPC 3 16729 00415 2; b) 1,00Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Doxazosin Tablets USP, 2 mg, Rx Only, Packaged as: a) 100-count bottle NDC 16729-414-01 UPC 3 16729 41401 2; b) 1,000-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glycopyrrolate Injection, USP, 0.4 mg/2 mL (0.2 mg/mL) 2 mL Single Dose Vial X 25 vials carton, Rx Only, Manufactured foClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Finasteride Tablets USP 1 mg, 90-count bottle, Keeps, Rx Only, Manufactured for: Thirty Madison, Inc. New York, NY 10016Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| BusPIRone Hydrochloride Tablets USP, 5 mg, Rx Only, Packaged as: a) 100 Tablets NDC 16729-200-01 UPC 3 16729 20001 1; b)Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 5 mg Rx Only, Packaged as a) 30-count bottle, NDC 16729-279-10, UPC 3 16729 27910 9; b) 100-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pravastatin Sodium Tablets USP, 80 mg, Rx Only, 90- count bottle, Manufactured for: Accord Healthcare, Inc., Durham, NC Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Doxazosin Tablets USP, 8 mg, Rx Only, Packaged in: a) 100 Tablets NDC 16729-415-01 UPC 3 16729 41501 9; b) 1,000 TabletsClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Pirfenidone Tablets 267 mg 90-count bottle x3/Carton, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 277Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Atorvastatin Calcium Tablets USP 40 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-046-15 UPC 3 16729 04615 2; b) 1,00Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Atorvastatin Calcium Tablets USP, 10 mg* Rx Only, Packaged as a) 90 Tablets NDC 16729-044-15 UPC 3 16729 04415 8; b) 1,Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glycopyrrolate Injection, USP 1 mg/5 mL (0.2 mg/mL) 5 mL Multiple Dose Vial, x 10 vials carton, Rx Only, Manufactured foClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Simvastatin Tablets USP 20 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-005-15, UPC 3 16729 00515 9; b) 1,000-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 15 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-281-10, UPC 3 16729 28110 2; b) 100-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Rosuvastatin Tablets, USP 40 mg* Rx Only, Packaged as: a) 30-count bottle NDC 16729-287-10, UPC 3 16729 28710 4; b) 90-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Dofetilide Capsules, 125 mcg (0.125 mg), 60-count bottle, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NCClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Glimepiride Tablets USP, 4 mg, Rx Only, Packaged in: a) 100-count bottle NDC 16729-003-01 UPC 3 16729 00301 8; b) 500-coClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Daptomycin for Injection 350 mg/vial, Rx only, Packaged as: a) Single-dose vial NDC 16729-434-05 UPC 3 16729 43405 8; b)Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Simvastatin Tablets USP 80 mg Rx Only, Packaged as: a) 90-count bottle NDC 16729-007-15, UPC 3 16729 00715 3; b) 1,000-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-cClass IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Aripiprazole Tablets, USP 2 mg, Rx Only, Packaged as a) 30-count bottle, NDC 16729-278-10, UPC 3 16729 27810 2; b) 100-Class IIFeb 7, 2023CGMP Deviations: recalling drug products following an FDA in |
| Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703,Class IIJan 12, 2023Presence of Foreign Substance: Presence of a small piece of |
| Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC Class INov 29, 2022Labeling mixup: cartons labeled as Daptomycin 350 mg/vial we |
| Glycopyrrolate Injection, USP 0.4 mg/2 mL (0.2 mg/mL) 25 x 2 mL Single Dose Vials Rx Only, Manufactured for: Accord HealClass IIIJan 28, 2021Labeling; Label Mix-up; correctly labeled 2 mL vials were pa |