FDA Drug recall D-0385-2015
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Mar…
- FDA Drug
- Class II
- terminated
- Published 2015-02-18
On 2015-02-18 the FDA classified a Class II recall of Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Mar… by Akorn, citing microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0385-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-28 |
| Published | 2015-02-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Akorn |
| Distribution | US |
Product
Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPharm Incorporated, Marietta, GA 30062, NDC 61748-202-60 .
Reason
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Identifiers
| code_info | Lot # 1446800; Exp. 03/15 Lot # 1538100; Exp. 05/15 Lot # 1538101; Exp. 05/15 Lot # 1538200; Exp. 06/15 Lot # 1608200; Exp. 08/15 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0385-2015%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.