Why it was recalled
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Product description
Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
Lot numbers, UPCs & expiration codes
Lot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Where it was sold
U.S.A. 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-1029-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 17, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 2576 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Science Limited
Original FDA data
Every field from FDA enforcement report D-1029-2020, exactly as published.
Show all FDA fields
- City
- Bangalore
- Status
- Terminated
- Country
- India
- Event ID
- 84968
- Address
- Krs Gardens, No.36/7 Suragajakkanahalli
- Address (line 2)
- Indlawadi Cross, Anekal Taluk
- Code information
- Lot #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1029-2020
- Classification
- Class III
- Recalling firm
- Strides Pharma Science Limited
- Product quantity
- 2576 bottles
- Termination date
- Feb 16, 2021
- Reason for recall
- Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Extended-Release Tablets USP, 10mEq (750mg), 1000-count bottle, Rx only, Manufactured by: Strides Shasun Limited Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-861-08
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Feb 17, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 13, 2020