Drug product
Potassium Citrate Extended-Release Tablets, USP, 15 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc. Yardley, PA 19067, Manufactured by: Strides Shasun Limited, Puducherry - 605 014, India, NDC 42543-408-01.
D-1017-2018
Product summary
- Event
- Event 80553
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,652 bottles
- Official record key
drug-enforcement:D-1017-2018
Official wording
Reason: Failed Tablet/Capsule Specifications: Tablet breakage
Code information: Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.
Distribution pattern: Within the United States and Puerto Rico.
Derived failure modes
-
Unknown
Failed Tablet/Capsule Specifications: Tablet breakage