1% Clotrimazol cream — Class II drug recall D-1043-2016
Terminated recall by Profarma Distributors LLC, reported 2016-06-29, distributed nationwide. CGMP Deviations
| Recall number | D-1043-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Profarma Distributors LLC, Columbus, OH, United States |
| Recall initiated | 2016-05-11 |
| Classified | 2016-06-17 |
| Reported by FDA | 2016-06-29 |
| Terminated | 2017-01-24 |
| Distributed | Nationwide (US) |
| Reason classes | cgmp |
| Lot numbers | 08/17, GRU1390 |
Product
1% Clotrimazol cream, 30 mg tube, UPC 501318644335
Reason for recall
CGMP Deviations
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-1043-2016. 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.