Multi event Drug Recall Enforcement Report Class II voluntary initiated by VENSUN PHARMACEUTICALS INC, originally initiated on 07-18-2018 for the 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. The product was recalled due to failed tablet/capsule specifications: tablet breakage. The product was distributed in Within The United States And Puerto Rico. and the recall is currently terminated.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-1018-2018 | 07-18-2018 | 08-08-2018 | Class II | 3,683 bottles | 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. | Failed Tablet/Capsule Specifications: Tablet breakage | Terminated |
| D-1017-2018 | 07-18-2018 | 08-08-2018 | Class II | 11,652 bottles | 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. | Failed Tablet/Capsule Specifications: Tablet breakage | Terminated |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 42543-406 | Potassium Citrate EXTENDED RELEASE | Potassium Citrate | Tablet | Oral | Strides Pharma Inc. | Human Prescription Drug |
| 42543-407 | Potassium Citrate EXTENDED RELEASE | Potassium Citrate | Tablet | Oral | Strides Pharma Inc. | Human Prescription Drug |
| 42543-408 | Potassium Citrate EXTENDED RELEASE | Potassium Citrate | Tablet | Oral | Strides Pharma Inc. | Human Prescription Drug |
