D-1017-2018 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- August 8, 2018
- Initiation Date
- July 18, 2018
- Termination Date
- April 16, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 11,652 bottles
Product Description
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
Distribution Pattern
Within the United States and Puerto Rico.
Code Information
Lot #: 9570024, Exp. Jun-2019; 9570027, 9570029, Exp. Jul-2019; 7702088A, 7702089A, Exp. Aug-2019.