Recall archive
35 recalls · page 2 of 2
Reported Dec 5, 2018
Nitrofurantoin Monohydrate/Macrocrystals capsules,100 mg, packaged in HDPE 60 cc bottles, Rx only, MFG: Sandoz Inc.,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.RemedyRepack Inc.
Matched: Brand · Product details — Cross contamination with other products: Product is being recalled due to the potential presence of unrelated ingredients (Benazepril, Haloperidol…
FDA (openFDA drug enforcement)
Reported Nov 21, 2018
Metoprolol Tartrate Injection, USP 5mg/5mL, vials, Rx only, MFG: Claris Lifesciences Inc., North Brunswick, NJ 08902,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.RemedyRepack Inc.
Matched: Brand — Failed pH Specifications: High Out-of-Specification results for pH were obtained during stability testing.
FDA (openFDA drug enforcement)
Reported Oct 31, 2018
Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
FDA (openFDA drug enforcement)
Reported Sep 5, 2018
Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand — CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
FDA (openFDA drug enforcement)
Reported Aug 22, 2018
Valsartan 80 mg Tablet,s HDPE 90 cc bottles in cardboard trays, Rx Only, RemedyRepack, Inc., 625 Kolter Drive, Suite 4,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Aug 8, 2018
Valsartan/HCTZ 160 mg/12.5 mg tablet, 90-count bottle, Rx only, RemedyRepack, 625 Kolter Drive, Suite 4, Indiana, PA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product · Product details — CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 4, 2017
Ketorolac Trom 30 mg/mL Injection, packaged in a) 1 mL vials, NDC 61786-0741-01 (Orig: 00548-9021-00), Ref: 33631 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Crystallization: Product is being recalled due to the manufacturer's recall due to the presence of visible particulate in vials that has been…
FDA (openFDA drug enforcement)
Reported Mar 1, 2017
Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsippany, NJ 07054, Repackaged by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Dec 16, 2015
Humulin 70/30, 100 Units/mL Inj, Qty: 10 mL Vial, MFG by: Lilly USA, LLC, Indianapolis, IN 46285, Repackaged by: Remedy…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Reason for recall — Labeling: Incorrect Instructions; RemedyRepack, Inc. a relabeler, is recalling these products due to incorrect storage instructions.
6 more products in this recall
FDA (openFDA drug enforcement)
Reported May 13, 2015
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Crystallization
FDA (openFDA drug enforcement)
Reported Apr 15, 2015
KETOROLAC TROM 30 MG/ML INJ, 1 mL glass vials repackaged individually inside an amber glass bottle, packaged by…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.RemedyRepack Inc.
Matched: Brand · Product details — Crystallization
FDA (openFDA drug enforcement)
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