Recalls / Class II
Class IID-0006-2022
Product
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.
- Brand name
- Potassium Chloride
- Generic name
- Potassium Chloride
- Active ingredient
- Potassium Chloride
- Route
- Oral
- NDCs
- 64380-860, 64380-861
- FDA application
- ANDA210733
- Affected lot / code info
- Lot 7240840A, exp. 12/31/2021
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Strides Pharma Inc.
- Manufacturer
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2 Tower Center Blvd Ste 1102, N/A, East Brunswick, New Jersey 08816-1100
Distribution
- Quantity
- 1813 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-09-27
- FDA classified
- 2021-10-08
- Posted by FDA
- 2021-10-20
- Terminated
- 2022-10-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0006-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.