Recalls / Class II
Class IID-0385-2015
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 .
- Affected lot / 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
Why it was recalled
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Recalling firm
- Firm
- Akorn, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1925 W. Field Court, Suite 300, N/A, Lake Forest, Illinois 60045
Distribution
- Quantity
- 23,449 jars
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-01-28
- FDA classified
- 2015-02-10
- Posted by FDA
- 2015-02-18
- Terminated
- 2017-11-30
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0385-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.