Why it was recalled
CGMP Deviations
Product description
Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
Lot numbers, UPCs & expiration codes
Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.
Where it was sold
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-0607-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 30, 2024
- FDA report date
- Jul 24, 2024
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
Original FDA data
Every field from FDA enforcement report D-0607-2024, exactly as published.
Show all FDA fields
- City
- Mahwah
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94715
- Address
- 750 Corporate Dr
- Code information
- Lot #: 17230186, 17230192, 17230213, 17230278, 17230399, Exp Dec-31-24; 17230406, 17230412, 17230427, 17230444, 17230453, 17230495, Exp Jan-31-25; 17230574, 17230585, 17230608, 17230629, Exp Feb-28-25; 17230883, 17230921, Exp Mar-31-25; 17231087, 17231339, Exp Apr-30-25; 17231360, Exp May-31-25; 17231711, 17231745, Exp Jun-30-25; 17231819, 17231820, 17231936, 17231957, Exp Jul-31-25; 17231998, 17232012, Aug-31-25; 17232110, Exp Sep-30-25; 17232114, Exp Aug-31-25; 17232119, 17232343, Exp Sep-30-25.
- Postal code
- 07430-2009
- Report date
- Jul 24, 2024
- Product type
- Drugs
- Recall number
- D-0607-2024
- Classification
- Class II
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Plot No. 2, Phase-2, Pharma Zone SEZ, Pithampur, Dist.-Dhar, Madhya Pradesh 454 775, India, Manufactured for: Glenmark Pharmaceuticals Inc, USA, Mahwah, NJ 07430. NDC 68462-357-05
- Distribution pattern
- Nationwide
- Recall initiation date
- May 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Jul 17, 2024