FDAFDA · Food and drugs·Recall number D-0848-2022
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
Published May 11, 2022 · Recall initiated: April 21, 2022
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- McKesson Corporation dba McKesson Drug Company
- Distributor
- Nationwide in the United States including Guam and the Northern Mariana Islands.
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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