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Class II Recall
Teligent Pharma, Inc.
Product
Halobetasol Propionate Ointment, 0.05%, Net Wt. 50 grams 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 63739-998-67.
Reason
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Classification
Class II
Status
Terminated
Lot
Batch: 15720, Exp. 6/30/2022; 16449, 16450, Exp. 2/28/2023
Date
2022-03-30
Disclaimer:
This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.