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 Onl

Recalled March 30, 2022 · FDA recall D-0686-2022 · Teligent Pharma

Hazard

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. · FDA Class II

Units

355,672 tubes

Sold at

Nationwide in the USA and Puerto Rico

Description

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Product

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.

Manufacturer(s)

Teligent Pharma, Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →