Carbamazepine 200 mg Tablets — Class II drug recall D-1387-2020
Terminated recall by RemedyRepack Inc., reported 2020-07-22, distributed in MN. FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine s
| Recall number | D-1387-2020 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | RemedyRepack Inc., Indiana, PA, United States |
| Recall initiated | 2020-06-29 |
| Classified | 2020-07-14 |
| Reported by FDA | 2020-07-22 |
| Terminated | 2020-09-14 |
| Distributed | MN |
| Quantity | 498 tablets |
| Reason classes | specification failure |
| NDC | 70518-2489-00, 70518-2489-01 |
| Lot numbers | B0796217-020920 |
| Expiration dates | 2021-02-28 |
Product
Carbamazepine 200 mg Tablets, 100-unit dose tablets per box, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2489-00 for box; 70518-2489-01 per unit dose.
Reason for recall
FAILED DISSOLUTION SPECIFICATION: Low out-of-specification (OOS) dissolution results obtained during routine stability testing.
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-1387-2020. 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.