RemedyRepack recalls
FDA enforcement reports naming RemedyRepack Inc. as the recalling firm.
- Recall reports
- 61
- Class I (serious)
- 1
- Most recent report
- May 14, 2025
- May 14, 2025Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: R…Drug · RemedyRePack Inc.CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.Class II
- Apr 30, 2025Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: R…Drug · RemedyRepack Inc.CGMP DeviationsClass II
- Feb 12, 2025Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx On…Drug · RemedyRepack Inc.CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.Class II
- Jan 1, 2025Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-0…Drug · RemedyRepack Inc.CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.Class II
- Jul 24, 2024Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister c…Drug · RemedyRepack Inc.CGMP Deviations: Out of specification for dissolutionClass II
- Jun 19, 2024Phenazopyridine HCl, 100mg tablets, 6 count bottles, Rx Only, Repackaged by: RemedyRepa…Drug · RemedyRepack Inc.Product Mix Up. A bottle labeled as Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.Class II
- May 15, 2024TraMADol HCl 50 mg Tablet, Packaged as (a) 30-count blister packDrug · RemedyRepack Inc.Presence of Foreign Tablets: Manufacturer received a report from a Pharmacist who reported finding a tablet of baclofen in a bottle of 1000-count tramadolClass II
- May 24, 2023Pyrazinamide, 500 mg Tablet, packaged in a) 29 x 30-count cardDrug · RemedyRepack Inc.CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.Class II
- May 24, 2023Ketotifen Fumarate 0Drug · RemedyRepack Inc.CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.Class II
- May 24, 2023LORazepam Injection, 2mg / mL Single Dose vial 1ml vial, Rx Only, MFG Akorn Lake Fores…Drug · RemedyRepack Inc.CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.Class II
- Ropinirole 0
- Glimepiride 2 mg tablets, packaged in a) 30-count bottles (NDC 70518-0405-03), b) 90-co…
- Doxazosin 2 mg tablets, packaged in a) 30-count (NDC 70518-1560-00) and b) 90-count b…
- Atorvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-1946-00) and b)…
- Aripiprazole 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b) 9…
- Rosuvastatin 40mg tablets, packaged in a) 45-count bottles (NDC 70518-1311-01), and b)…
- Rosuvastatin 10mg tablets, packaged in a) 30-count bottles (NDC 70518-0375-03 and 70518…
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by: RemedyRe…
- Atorvastatin 20 mg tablets, packaged in a) 30-count bottles (NDC 70518-1977-00) and b)9…
- Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b) 9…
- Rosuvastatin 5mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc
- Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore…
- Desmopressin Acetate Tablet, 0
- Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore,…
- Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original…
- Losartan HCTZ 50/12
- Losartan HCTZ 100/12
- Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-co…
- Metformin 750 mg Extended Release NDC # 70518-2920-00
- Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count…
- Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, N…
- Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repac…
- Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: Re…
- Lisinopril/HCTZ 20mg/12
- Ketorolac Trom, 30 mg/1mL Inj
- Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC…
- Losartan Potassium/HCTZ, 100 mg/12
- Losartan 50mg Tablet, 30 count each blister card
- Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottle…
- Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc
- Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard t…
- Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboa…
- Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack,…
- Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack,…
- Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc
- Valsartan/HCTZ 320mg/12
- Valsartan/HCTZ 160 mg/12
- Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials
- Glipizide 2
- Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis,…
- Rocuronium Bromide 50 MG/5ML INJ
- Novolin 70/30, 100 Units/mL Solu
- Lorazepam 2 mg/mL Inj
- Ascorbic Acid 500 MG/ML Inj
- Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rock…
- Bicillin L-A 600000 Units/mL Inj
- KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber g…
- KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber…
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