PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: January 5, 2022 Initiated: November 30, 2021 #D-0296-2022

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: Minimally superpotent

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
7,176 bottles
Distribution
Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Location
Buena, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Teligent Pharma, Inc.. Units affected: 7,176 bottles.
Why was this product recalled?
Superpotent Drug: Minimally superpotent
Which agency issued this recall?
This recall was issued by the FDA Drug on January 5, 2022. Severity: Moderate. Recall number: D-0296-2022.