RemedyRePack Recalls
61 recalls on record · April 15, 2015 to May 14, 2025 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
May 4, 2022DrugsFDA
RemedyRepack Inc. recalls Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
January 19, 2022DrugsFDA
RemedyRepack Inc. recalls Metformin 750 mg Extended Release NDC # 70518-2920-00
Hazard: CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
January 12, 2022DrugsFDA
RemedyRepack Inc. recalls Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03),
Hazard: Failed Impurities/Degradation Specifications
September 1, 2021DrugsFDA
RemedyRepack Inc. recalls Carvedilol 25 mg, 180-count bottle, Rx only, Manufactured by Zydus Pharm, Pennington, NJ 08534, NDC 68382-0095-05, Repac
Hazard: A 500 count bottle of Carvedilol 25 mg tablets contained two Paroxetine Tablets, 40 mg. Product was repackaged into 180 count bottles.
November 4, 2020DrugsFDA
RemedyRepack Inc. recalls Metformin Hydrochloride Extended Release 750 mg, 30 count blister cards, Rx only, Repackaged by: RemedyRepack Inc., Indi
Hazard: CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
July 22, 2020DrugsFDA
RemedyRepack Inc. recalls Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 1570
Hazard: FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
March 25, 2020DrugsFDA
RemedyRepack Inc. recalls Lisinopril/HCTZ 20mg/12.5mg Tablet, QTY: 30 tablets per blister card, MFG: Lupin Pharma Baltimore, MD 21202, NDC 68180-0
Hazard: Presence of Foreign Tablets/Capsules: This is a spin-off recall of D-1581-2019 due to a product complaint where one of Lupin's Fenofibrate 145mg was observed in the 500 s count product bottle.
February 19, 2020DrugsFDA
RemedyRepack Inc. recalls Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repackaged by: RemedyRepack Inc., Indiana, PA 1570
Hazard: Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer due to small black particles noticed during routine visual inspection. of retain samples.
January 29, 2020DrugsFDA
RemedyRepack Inc. recalls Ranitidine 150 mg tablet Original Supplier's NDC 65162-0253-10 Remedy Repackaged NDC 70518-1714-00
Hazard: CGMP Deviation; Received notice from supplier of potential -Nitrosodimethylamine (NDMA) amounts above established levels.
May 8, 2019DrugsFDA
RemedyRepack Inc. recalls Losartan Potassium/HCTZ, 100 mg/12.5 mg Tablet, 90-Count bottle, Manufactured by Torrent Pharmaceuticals, Distributed by
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level of 0.96 parts per million.
April 17, 2019DrugsFDA
RemedyRepack Inc. recalls Losartan 50mg Tablet, 30 count each blister card.
Hazard: CGMP Deviations; Detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) - N-Methylnitrosobutyric acid (NMBA).
December 5, 2018DrugsFDA
RemedyRepack Inc. recalls Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc., Pri
Hazard: Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol and Perphenazine).
November 21, 2018DrugsFDA
RemedyRepack Inc. recalls Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902, ND
Hazard: Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
October 31, 2018DrugsFDA
RemedyRepack Inc. recalls Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30
Hazard: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
September 5, 2018DrugsFDA
RemedyRepack Inc. recalls Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD,
Hazard: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 320 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 160 mg Tablets, HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 22, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan/HCTZ 320mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 1570
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
August 8, 2018DrugsFDA
RemedyRepack Inc. recalls Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA 157
Hazard: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
October 4, 2017DrugsFDA
RemedyRepack Inc. recalls Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and b)
Hazard: Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been identified as crystalline ketorolac calcium salt.
March 1, 2017DrugsFDA
RemedyRepack Inc. recalls Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by RemedyRepack
Hazard: Failed Dissolution Specifications
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Rocuronium Bromide 50 MG/5ML INJ., Qty: 5 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: Remed
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Novolin 70/30, 100 Units/mL Solu., Qty: 1 Vial, MFG by: Novo Nordisk, A/S, Bagsvaerd, Denmark DK-2880, Repackaged by: Re
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Lorazepam 2 mg/mL Inj., Qty: 1 mL Vial, MFG by: West-Ward Pharma, Eatontown, NJ 07724, Repackaged by: RemedyRepack Inc.,
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Ascorbic Acid 500 MG/ML Inj., Qty: 50 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: RemedyRep
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Vitamin B-Complex 100, Multi MG Inj, Qty: 30 mL Vial, MFG by: Mylan Institutional, Rockford, IL 61103, Repackaged by: Re
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Bicillin L-A 600000 Units/mL Inj., Qty: 20 mL Syringe, MFG by: King Pharma Inc., Bristol, TN 37620, Repackaged by: Remed
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
December 16, 2015DrugsFDA
RemedyRepack Inc. recalls Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy
Hazard: Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
May 13, 2015DrugsFDA
RemedyRepack Inc. recalls KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by RemedyRe
Hazard: Crystallization