Gentamicin Sulfate Cream USP recalled over manufacturing violations
- Recall date
- March 15, 2022
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Teligent Pharma, Inc. recalls Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx On…
- Recall number
- D-0686-2022
- FDA classification
- Class II
- Brand / firm
- Teligent Pharma, Inc.
- Sold / distributed
- Nationwide in the USA and Puerto Rico
Why it was recalled
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.
Get recall alerts
Free email alert whenever Teligent Pharma, Inc. has a new recall — straight from official government data. Unsubscribe anytime.
More recalls from: Teligent Pharma, Inc.