Drug recall D-1017-2018
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.
Reason for recall
Failed Tablet/Capsule Specifications: Tablet breakage
Lots and codes
Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.
Recall details
- Recalling firm
- VENSUN PHARMACEUTICALS INC, Yardley, PA
- Quantity
- 11,652 bottles
- Distribution
- Within the United States and Puerto Rico.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 18, 2018
- Terminated
- April 16, 2019
Related products
- Potassium Citrate – drug information
- NDC 42543-408 Potassium Citrate Extended Release · Potassium Citrate 15 meq/1 · Strides Pharma Inc.
- NDC 42543-406 Potassium Citrate Extended Release · Potassium Citrate 5 meq/1 · Strides Pharma Inc.
- NDC 42543-407 Potassium Citrate Extended Release · Potassium Citrate 10 meq/1 · Strides Pharma Inc.