Topical Antibiotic Recalled

Teligent Pharma Inc is voluntarily recalling four lots of erythromycin topical solution 2% for failing to meet impurity/degradation specifications, according to the July 28, 2021, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects the following erythromycin products, which were distributed throughout the United States:

• erythromycin topical solution 2%, 60 mL (NDC 52565-027-59), from lot 14180 (no expiration date or manufacturer was listed on the report);
• erythromycin topical gel 2%, 30 g (NDC 52565-033-30), manufactured by Teligent Pharma, Buena, NJ, from lot 14010 (Exp. 7/21); and
• erythromycin topical gel 2%, 60 g (NDC 52565-033-60), manufactured by Teligent Pharma, Buena, NJ, from lots 13865 (Exp. 6/21) and 14011 (Exp. 7/21).

Teligent Pharma initiated the recall June 22, 2021. On July 19, 2021, the FDA designated the recall Class III, suggesting use of the recalled drugs is not likely to cause harm.

Erythromycin topical solution is a prescription macrolide antibiotic used to treat certain eye infections as well as to prevent them in newborns.