Clindamycin Phosphate Topical Solution USP — Class III drug recall D-1208-2019
Terminated recall by Akorn, Inc., reported 2018-12-05, distributed nationwide. Failed Impurities/Degradation Specifications; out of specification results observed for other individual impur
| Recall number | D-1208-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Decatur, IL, United States |
| Recall initiated | 2018-10-29 |
| Classified | 2019-04-23 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2022-08-09 |
| Distributed | Nationwide (US) |
| Quantity | 58,393 jars |
| Reason classes | specification failure |
| NDC | 61748-0201-60 |
| Lot numbers | 2530200, 2530300, 2530400, 2607300, 2607400, 2607500, 2607600, 2615800, 2630200, 2630300 |
| Expiration dates | 2019-01-31, 2019-02-28 |
Product
Clindamycin Phosphate Topical Solution USP, 1% (10 mg/mL clindamycin), 60 pledget applicators per jar, Rx only. Manufactured by Ei LLC 2865 N. Cannon Blvd. Kannapolis, NC 18083. NDC# 61748-0201-60
Reason for recall
Failed Impurities/Degradation Specifications; out of specification results observed for other individual impurities
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-1208-2019. 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.