Potassium Citrate Extended-Release Tablets — Class II drug recall D-1017-2018
Terminated recall by VENSUN PHARMACEUTICALS INC, reported 2018-08-08, distributed in PR. Failed Tablet/Capsule Specifications: Tablet breakage
| Recall number | D-1017-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | VENSUN PHARMACEUTICALS INC, Yardley, PA, United States |
| Recall initiated | 2018-07-18 |
| Classified | 2018-07-27 |
| Reported by FDA | 2018-08-08 |
| Terminated | 2019-04-16 |
| Distributed | PR |
| Quantity | 11,652 bottles |
| Reason classes | device malfunction |
| NDC | 42543-0406, 42543-0406-01, 42543-0407, 42543-0407-01, 42543-0408, 42543-0408-01 |
| Lot numbers | 7702088A, 7702089A, 9570024, 9570027, 9570029, AUG-2019, JUL-2019, JUN-2019 |
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
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1017-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.