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Recall Observatory FDA recall evidence

Drug 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

D-0848-2022

April 21, 2022

Class II

Product summary

Firm
McKesson Corporation dba McKesson Drug Company
Event
Event 89986
Status
Ongoing
Classification
Class II
Quantity
81,757 bottles
Official record key
drug-enforcement:D-0848-2022

Official wording

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

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

Distribution pattern: Nationwide in the United States including Guam and the Northern Mariana Islands.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations