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Teligent Pharma, Inc. FDA Recalls
59 recalls on file across drugs, 3 of them Class I and 5 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 |
|---|
| Fluocinonide Cream USP, 0.1%, 120 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310, Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., AmitClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Triamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 5256Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Triamcinolone Acetonide Ointment USP, 0.5%, Net Wt. 15 grams tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 083Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton RoClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Cream USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-051-15; b) 30 grams tube, NDC 52565-051-Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Hydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton RoClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Desoximetasone Ointment USP, 0.05%, packaged in a) 100 grams tubes, NDC 52565-045-99; b) 60 grams tubes, NDC 52565-045-6Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b)Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottles, Rx Only, Manufactured for: SOLA PharmaceutClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Gel, 0.05%, packaged in a) 15 grams tube, NDC 52565-082-15; b) 30 grams tube, NDC 52565-082-30; c)Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Desonide Ointment, 0.05%, packaged in a) 15 g tubes, NDC 52565-038-15; b) 60 g tubes, NDC 52565-038-60, Rx Only, ManufacClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Lotion, 0.05%, packaged in a) 2 fl. oz. (59 mL) bottles, NDC 52565-055-02; b) 4 fl. oz. (118 mL) bClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Lidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 oz) tube, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDCClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-6Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx OnlClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Lidocaine Cream, 4%, packaged in a) Net Wt. 15 grams tubes, NDC 52565-122-15; b) Net Wt. 30 grams tubes, NDC 52565-122-3Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Diclofenac Sodium Topical Solution USP, 1.5% w/w, 5 fl. oz. (150 mL) bottle, Rx only, Teligent Pharma, Inc., Buena, New Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Ointment USP, 0.05%, packaged in a) 15 grams tube, NDC 52565-039-15; b) 30 grams tube, NDC 52565-0Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-02Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC BatonClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Fluocinonide Gel USP, 0.05%, packaged in a) 15 g tubes, NDC 52565-054-15; b) 60 g tubes, NDC 52565-054-60; c) 30 g tubesClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Halobetasol Propionate Ointment, 0.05%, packaged as a) 15 g tubes, NDC 52565-073-15; b) 50 g tubes, NDC 52565-073-51, RxClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Gentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, BaClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Cream USP, 0.05% (Emollient), packaged in a) 15 grams tube, NDC 52565-094-15; b) 30 grams tube, NDClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 0Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Clobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, BatonClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Lidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, LivoClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams tube, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Hydrocortisone Butyrate Lotion, 0.1%, packaged in a) 2 fl oz (59 mL) bottles, NDC 52565-087-02; b) 4 fl oz (118 mL) bottClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, NewClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Nystatin and Triamcinolone Acetonide Ointment, USP, packaged in a) 15 grams tubes, NDC 52565-042-15; b) 30 grams tubes, Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Triamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-0Class IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Desoximetasone Ointment USP, 0.05%, Net Wt. 100 grams tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton RougClass IIMar 15, 2022cGMP deviations: all products within expiry are being recall |
| Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, DiClass IIFeb 7, 2022Failed Impurities/Degradation Specifications: Lot not meetin |
| Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, ManufacturedClass INov 30, 2021Superpotent Drug |
| Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, ManufacturedClass IINov 30, 2021Superpotent Drug: Minimally superpotent |
| Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., BuenaClass IIOct 19, 2021Defective Container |
| Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., BuenaClass IIOct 19, 2021Defective Container |
| Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NClass IOct 12, 2021Superpotent Drug |
| Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NClass IIOct 12, 2021CGMP Deviations: Lots recalled because they were manufacture |
| Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent PharClass IIOct 12, 2021CGMP Deviations: Lots recalled because they were manufacture |
| Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only, Teligent Pharma Inc., Buena, NClass IIAug 23, 2021Failed Stability Specifications: lot did not meet specificat |
| Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New JerseyClass IAug 3, 2021Superpotent Drug |
| Erythromycin Topical Solution USP, 2%, 60mL bottle, Rx only, Teligent Pharma, Inc. Buena, NJ 08310, NDC 52565-027-59Class IIJul 29, 2021Defective container: possibility for lack of seal integrity. |
| Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, NewClass IIIJul 29, 2021Failed Viscosity Specifications: lot does not meet specifica |
| Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-0Class IIJul 19, 2021Correct Labeled Product Mispack |
| Triamcinolone Acetonide Ointment USP, 0.1% 80 g cartons, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52Class IIJul 19, 2021Correct Labeled Product Mispack |
| Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Class IIIJun 22, 2021Failed Impurities/Degradation Specifications |
| Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59Class IIIJun 22, 2021Failed Impurities/Degradation Specifications |
| Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-15) and b) 30 g (NDC 52565-063-30) tubes, RClass IIMay 14, 2021Presence of Foreign Substance: Foreign particles observed du |
| Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565Class IIApr 9, 2021Failed Impurities/Degradation Specifications: |
| Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDCClass IIIMar 29, 2021Failed Stability Specifications: product did not meet viscos |
| Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent PharmaClass IIIFeb 2, 2021Failed Impurities/ Degradation Specifications - OOS for kno |
| Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent PharmClass IIIFeb 2, 2021Failed Impurities/ Degradation Specifications - OOS for kno |
| Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent PharmaClass IIIFeb 2, 2021Failed Impurities/ Degradation Specifications - OOS for kno |