Steroid Ointment Recalled

Teligent Pharma Inc. is voluntarily recalling nine lots of betamethasone dipropionate ointment for failing to meet impurity specifications during testing, according to the May 5, 2021, US Food and Drug Administration (FDA) Enforcement Report. 

The recall affects the following products, which were manufactured by Teligent Pharma Inc. Buena, NJ, and distributed throughout the United States:

• betamethasone dipropionate ointment, 0.05% (augmented), packaged in 15-gram tubes (NDC 52565-019-15), from lots 14297 (Exp. 9/21), 15372 (Exp. 3/22), and 15841 (Exp. 8/22);
• betamethasone dipropionate ointment, 0.05% (augmented), packaged in 50-gram tubes (NDC 52565-019-51), from lots 14297 (Exp. 9/21), 15757 (Exp. 6/22), 15840 (Exp. 7/22), 15970 (Exp. 9/22), and 15993 (Exp. 9/22); and
• betamethasone dipropionate ointment, 0.05% (augmented), packaged in 15-gram tubes (NDC 63739-996-15), from lot 15644 (Exp. 5/22). Ointment from lot 15644 was distributed by McKesson Corporation, doing business as Sky Packaging, the FDA noted. 

Teligent Pharma initiated the recalls February 2, 2021. On April 23, 2021, the FDA designated the recalls Class III, suggesting use of the recalled ointment is not likely to cause harm.

Betamethasone dipropionate is a prescription steroid used to treat a variety of skin conditions, such as eczema, dermatitis, and rash.

There was a similar recall last week from Teligent Pharma Inc for a different topical steroid.

—Jolynn Tumolo