Recalls / Class III
Class IIID-1029-2020
Product
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
- 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 #: 7238958A, 7238257A, Exp 7/31/2021; 7239404A, Exp 9/30/2021
Why it was recalled
Failed Tablet/Capsules Specifications: Oversized tablets were found in one lot of Potassium Chloride Tablets 750 mg.
Recalling firm
- Firm
- Strides Pharma Science Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Krs Gardens, No.36/7 Suragajakkanahalli, Indlawadi Cross, Anekal Taluk, Bangalore, N/A, India
Distribution
- Quantity
- 2576 bottles
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2020-02-17
- FDA classified
- 2020-03-13
- Posted by FDA
- 2020-03-25
- Terminated
- 2021-02-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1029-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.