Why it was recalled
Failed Dissolution Specifications
Product description
Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
Lot numbers, UPCs & expiration codes
Lot 7240840A, exp. 12/31/2021
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-0006-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 27, 2021
- FDA report date
- Oct 20, 2021
- Quantity
- 1813 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Strides Pharma Inc.
Original FDA data
Every field from FDA enforcement report D-0006-2022, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88759
- Address
- 2 Tower Center Blvd Ste 1102
- Code information
- Lot 7240840A, exp. 12/31/2021
- Postal code
- 08816-1100
- Report date
- Oct 20, 2021
- Product type
- Drugs
- Recall number
- D-0006-2022
- Classification
- Class II
- Recalling firm
- Strides Pharma Inc.
- Product quantity
- 1813 bottles
- Termination date
- Oct 26, 2022
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Potassium Chloride Extended-Release Tablets, USP 10 mEq (750 mg), 500 Tablets, Rx Only, Manufactured by: Strides Shasun Limited, Bengaluru - 562106, India, Distributed by: Strides Pharma In., East Brunswick, NJ 08816, NDC 64380-861-07.
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Oct 8, 2021