Drug product
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 15701, NDC 70518-1203-03
D-0611-2024
Product summary
- Event
- Event 94888
- Status
- Terminated
- Classification
- Class II
- Quantity
- 142 blister cards, 30 per blister card
- Official record key
drug-enforcement:D-0611-2024
Official wording
Reason: CGMP Deviations: Out of specification for dissolution
Code information: Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
Distribution pattern: USA Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
Out of specification