FDA-Drug2021-12-22Class II
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Teligent Pharma, Inc.
Hazard
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Sold states
Nationwide within the United States
Affected count
7,008 glass bottles
Manufactured in
105 Lincoln Avenue, Buena, NJ, United States
Products
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Manufactured by: Teligent Pharma Inc., Buena, NJ 06310, Distributed by: McKesson Corporation dba Sky Packaging, 497 Southridge Blvd, Suite 101, Memphis, TN 36141, NDC 63739-997-64.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2022Don't want to check this manually?
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