remedyrepack inc.
5 recalls on record
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RemedyRePack Inc. — Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02
CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.
FDAHealth
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FDAHealth
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RemedyRepack Inc. — Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister cards), Rx Only, MFG by: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA 15701,
CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended acceptable intake limit.
FDAHealth
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RemedyRepack Inc. — Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising P
CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit.
FDAHealth
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RemedyRepack Inc. — Potassium Chloride Micro 10mEq K (750 mg) Extended Release Capsules, 30-count blister card, Rx only, MFG: Glenmark, Mahwah, NJ 07430, Repackaged by: RemedyRepack Inc., Indiana, PA
CGMP Deviations: Out of specification for dissolution
FDAHealth