PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: December 22, 2021 Initiated: October 12, 2021 #D-0279-2022

Product Description

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.

Reason for Recall

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.

Details

Recalling Firm
Teligent Pharma, Inc.
Units Affected
7,008 glass bottles
Distribution
Nationwide within the United States
Location
Buena, NJ

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Teligent Pharma, Inc.. Units affected: 7,008 glass bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 22, 2021. Severity: Moderate. Recall number: D-0279-2022.

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