# FDA recall D-0385-2015

> **Akorn, Inc.** · Class II · drug recall initiated 2015-01-28.

## 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 for recall

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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0385-2015
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-01-28
- **Report date:** 2015-02-18
- **Termination date:** 2017-11-30

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0385-2015

## Citation

> AI Analytics. FDA recall D-0385-2015. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0385-2015. Source: US FDA. Licensed CC0.

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