Recalls / Class II
Class IID-0848-2022
Product
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
- Affected lot / code info
- 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
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.
Recalling firm
- Firm
- McKesson Corporation dba McKesson Drug Company
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4853 Crumpler Rd, N/A, Memphis, Tennessee 38141-8301
Distribution
- Quantity
- 81,757 bottles
- Distribution pattern
- Nationwide in the United States including Guam and the Northern Mariana Islands.
Timeline
- Recall initiated
- 2022-04-21
- FDA classified
- 2022-05-05
- Posted by FDA
- 2022-05-11
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0848-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.