Betamethasone Dipropionate Ointment USP recalled over manufacturing violations

Recall date

April 21, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

McKesson Corporation dba McKesson Drug Company recalls Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only…

Recall number

D-0850-2022

FDA classification

Class II

Brand / firm

McKesson Corporation dba McKesson Drug Company

Sold / distributed

Nationwide in the United States including Guam and the Northern Mariana Islands.

Why it was recalled

CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.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

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone), 15 gram tube, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-65