Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles...
FDA Recall #D-0295-2022 — Class I — November 30, 2021
Product Description
Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 mL screw cap bottles, Rx Only, Manufactured by Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-997-64
Reason for Recall
Superpotent Drug
Recalling Firm
Teligent Pharma, Inc. — Buena, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
6,816 bottles
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Code Information
Lot #: 16345, Exp. Date 01/2024
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated