D-0280-2022 Class I Terminated

Recalled by Teligent Pharma, Inc. — Buena, NJ

FDA drug recall D-0280-2022 was initiated by Teligent Pharma, Inc. on October 12, 2021 and is designated Class I. Reason for recall: Superpotent Drug The recall status is terminated (terminated June 18, 2024). Affected quantity: 52,104 glass bottles.

Recall Details

Product Type
Drugs
Report Date
December 22, 2021
Initiation Date
October 12, 2021
Termination Date
June 18, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
52,104 glass bottles

Product Description

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

Reason for Recall

Superpotent Drug

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022