FDA Drug recall D-1018-2018
Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc
- FDA Drug
- Class II
- terminated
- Published 2018-08-08
On 2018-08-08 the FDA classified a Class II recall of Potassium Citrate Extended-Release Tablets, USP, 10 mEq, 100-count bottles, Rx only, Manufactured for: Vensun Pharmaceuticals, Inc by Vensun Pharmaceuticals, citing failed Tablet/Capsule Specifications: Tablet breakage.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1018-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-18 |
| Published | 2018-08-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Vensun Pharmaceuticals |
| Distribution | PR |
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.
Reason
Failed Tablet/Capsule Specifications: Tablet breakage
Identifiers
| ndc | 42543-406-01 |
|---|---|
| ndc | 42543-407-01 |
| ndc | 42543-408-01 |
| code_info | Lot #: 9570012, Exp. June-2019 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1018-2018%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.