Recalls / Class II
Class IID-0611-2024
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
- Affected lot / code info
- Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
Why it was recalled
CGMP Deviations: Out of specification for dissolution
Recalling firm
- Firm
- RemedyRepack Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 625 Kolter Dr Ste 4, Indiana, Pennsylvania 15701-3571
Distribution
- Quantity
- 142 blister cards, 30 per blister card
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2024-06-26
- FDA classified
- 2024-07-18
- Posted by FDA
- 2024-07-24
- Terminated
- 2025-01-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0611-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.