D-0848-2022 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- May 11, 2022
- Initiation Date
- April 21, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 81,757 bottles
Product Description
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
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.
Distribution Pattern
Nationwide in the United States including Guam and the Northern Mariana Islands.
Code Information
Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024