Teligent Pharma, Inc. recalls Gentamicin Sulfate Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30

Recalled March 30, 2022 · FDA recall D-0687-2022 · 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

43,956 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 Ointment USP 0.1%, packaged as a) 15 grams tube, NDC 52565-090-15; b) 30 grams tube, NDC 52565-090-30, 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 →