RemedyRepack Inc. recalls
12 recalls on record · FDA
Every recall we have on record for RemedyRepack Inc., compiled from federal safety data. Check the hazard, the remedy, and how serious each one is, and always confirm on the official notice.
Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx…
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC…
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister…
CGMP Deviations: Out of specification for dissolution
Simvastatin 10 mg tablets, packaged in a) 30-count bottles (NDC 70518-0064-01) and b)…
cGMP Deviations
Ropinirole 2mg tablets, packaged in 180-count bottles, Rx only, Repackaged by:…
cGMP Deviations
Simvastatin 40 mg tablets, packaged in a) 30-count bottles (NDC 70518-0060-01) and b)…
cGMP Deviations
Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma, Baltimore,…
Failed Impurities/Degradation specifications
Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore,…
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original…
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Metformin 750 mg Extended Release NDC # 70518-2920-00
CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Daily Intake Limit.
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count…
Failed Impurities/Degradation Specifications