Why it was recalled
CGMP Deviations: Out of specification for dissolution
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
Where it was sold
USA Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0611-2024
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2024
- FDA report date
- Jul 24, 2024
- Quantity
- 142 blister cards, 30 per blister card
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0611-2024, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 94888
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: J0758674-021824, Exp 03/31/2025; J0751898-011424, Exp 01/31/2025
- Postal code
- 15701-3571
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0611-2024
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- 142 blister cards, 30 per blister card
- Termination date
- Jan 31, 2025
- Reason for recall
- CGMP Deviations: Out of specification for dissolution
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Jun 26, 2024
- Initial firm notification
- Center classification date
- Jul 18, 2024