Erythromycin Pledgets USP recalled over sterility concerns
- Recall date
- January 28, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Akorn, Inc. recalls Erythromycin Pledgets USP, 2%, 60-count jar,Rx only, Manufactured by Ei LLC, Kannapolis, NC 28083, Marketed by VersaPha…
- Recall number
- D-0385-2015
- FDA classification
- Class II
- Brand / firm
- Akorn, Inc.
- Sold / distributed
- Nationwide
Why it was recalled
Microbial Contamination of Non-Sterile Products: Active Pharmaceutical Ingredient (API) failed USP microbial tests.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
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 .
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