Drug 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 .
D-0385-2015
Product summary
- Firm
- Akorn, Inc.
- Event
- Event 70390
- Status
- Terminated
- Classification
- Class II
- Quantity
- 23,449 jars
- Official record key
drug-enforcement:D-0385-2015
Official wording
Reason: Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Code information: 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
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination