Recalls / Class II
Class IID-1018-2018
Product
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-407-01.
- Brand name
- Potassium Citrate
- Generic name
- Potassium Citrate
- Active ingredient
- Potassium Citrate
- Route
- Oral
- NDCs
- 42543-406, 42543-407, 42543-408
- FDA application
- ANDA206813
- Affected lot / code info
- Lot #: 9570012, Exp. June-2019
Why it was recalled
Failed Tablet/Capsule Specifications: Tablet breakage
Recalling firm
- Firm
- VENSUN PHARMACEUTICALS INC
- Manufacturer
- Strides Pharma Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 790 Township Line Rd, N/A, Yardley, Pennsylvania 19067-4248
Distribution
- Quantity
- 3,683 bottles
- Distribution pattern
- Within the United States and Puerto Rico.
Timeline
- Recall initiated
- 2018-07-18
- FDA classified
- 2018-07-27
- Posted by FDA
- 2018-08-08
- Terminated
- 2019-04-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1018-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.