Home / Recalls / Akorn, Inc. / D-0385-2015

D-0385-2015 Class II Terminated

Recalled by Akorn, Inc. — Lake Forest, IL

FDA drug recall D-0385-2015 was initiated by Akorn, Inc. on Jan 28, 2015 and is designated Class II. Reason for recall: Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests. The recall status is terminated (terminated Nov 30, 2017). Affected quantity: 23,449 jars.

Recall Details

Product Type: Drugs
Report Date: Feb 18, 2015
Initiation Date: Jan 28, 2015
Termination Date: Nov 30, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 23,449 jars

Product Description

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 for Recall

Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.

Distribution Pattern

Nationwide

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

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0385-2015
openFDA file date: Oct 27, 2026
Loaded by RegDataLab: Oct 29, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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