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RemedyRePack Inc. FDA Recalls
34 recalls on file across drugs, 0 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 |
|---|
| Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157Class IIApr 22, 2025CGMP Deviations - products manufactured in a shared facility |
| Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 157Class IIMar 24, 2025CGMP Deviations |
| Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ Class IIJan 24, 2025CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 |
| Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 7051Class IIDec 2, 2024CGMP Deviations; presence of N-nitroso-duloxetine impurity a |
| Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, MahwClass IIJun 26, 2024CGMP Deviations: Out of specification for dissolution |
| Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepack, Inc., Indiana, PA NDC#: 70518Class IIMay 31, 2024Product Mix Up. A bottle labeled as Phenazopyridine HCl tabl |
| TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister pack, NDC 70518-3824-00; (b) 90-count blister pack, NDC 7051Class IIMay 2, 2024Presence of Foreign Tablets: Manufacturer received a report |
| LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Forest IL 60045, Repackaged by: RemedyClass IIMay 1, 2023CGMP Deviations: Discontinuation of the Quality program by m |
| Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count card, NDC # 70518-2534-01; b) 1 x 100 UD box, NDC # 70518-25Class IIMay 1, 2023CGMP Deviations: Discontinuation of the Quality program by m |
| Ketotifen Fumarate 0.025 %, Antihistamine eye drops, 5mL bottle, MFG: Akorn, Lake Forrest IL 60045, Repackaged by: RemedClass IIMay 1, 2023CGMP Deviations: Discontinuation of the Quality program by m |
| Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b) 90-count bottles (NDC 70518-1946-Class IIMar 20, 2023cGMP Deviations |
| Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDCClass IIMar 20, 2023cGMP Deviations |
| Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-count bottles (NDC 70518-0405-00) aClass IIMar 20, 2023cGMP Deviations |
| Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-0Class IIMar 20, 2023cGMP Deviations |
| Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)90-count bottles (NDC 70518-1977-0Class IIMar 20, 2023cGMP Deviations |
| Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518-0375-01) and b) 90-count bottlesClass IIMar 20, 2023cGMP Deviations |
| Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b) 90-count bottles (NDC 70518-0484-Class IIMar 20, 2023cGMP Deviations |
| Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 90-count bottles (NDC 70518-0064-0Class IIMar 20, 2023cGMP Deviations |
| Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 90-count bottles (NDC 70518-0060-0Class IIMar 20, 2023cGMP Deviations |
| Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2921Class IIMar 20, 2023cGMP Deviations |
| Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519Class IIMar 20, 2023cGMP Deviations |
| Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count bottles (NDC 70518-1560-01), Rx onClass IIMar 20, 2023cGMP Deviations |
| Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-3519Class IIMar 20, 2023cGMP Deviations |
| Ropinirole 0.5 mg tablets, packaged in 90-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NClass IIMar 20, 2023cGMP Deviations |
| Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore, MD 21202, original NDC 68180-06Class IIDec 20, 2022Failed Impurities/Degradation specifications |
| Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., Class IIDec 5, 2022Subpotent Drug: repackaged product was recalled by the manuf |
| Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack IClass IISep 15, 2022Presence of Foreign Substance: Foreign material (metal piece |
| Losartan HCTZ 50/12.5 mg, 90 count bottle Original NDC# 33342-0050-10 Repackaged NDC# 70518-3231-00Class IIMay 4, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09Class IIMay 2, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09Class IIMay 2, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282Class IIApr 6, 2022CGMP Deviations- AZIDO Impurity levels observed to be above |
| Metformin 750 mg Extended Release NDC # 70518-2920-00Class IIDec 30, 2021CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) |
| Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03),Class IIDec 29, 2021Failed Impurities/Degradation Specifications |
| Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, RepacClass IIAug 17, 2021A 500 count bottle of Carvedilol 25 mg tablets contained two |