Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented) (Potency expressed as betamethasone),...
FDA Recall #D-0850-2022 — Class II — April 21, 2022
Product Description
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
Reason for Recall
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Recalling Firm
McKesson Corporation dba McKesson Drug Company — Memphis, TN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
55,440 tubes
Distribution
Nationwide in the United States including Guam and the Northern Mariana Islands.
Code Information
Lot: 15644, Exp.: 05/31/2022
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated