D-0691-2022 Class II Terminated
FDA drug recall D-0691-2022 was initiated by Teligent Pharma, Inc. on March 15, 2022 and is designated Class II. Reason for recall: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program. The recall status is terminated (terminated June 17, 2024). Affected quantity: 21,323 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 30, 2022
- Initiation Date
- March 15, 2022
- Termination Date
- June 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 21,323 tubes
Product Description
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 for Recall
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
Distribution Pattern
Nationwide in the USA and Puerto Rico
Code Information
Batch: 15720, Exp. 6/30/2022; 16449, 16450, Exp. 2/28/2023