FDA Recall D-0800-2021

Teligent Pharma, Inc. · Buena, NJ

Class I — life-threatening Ongoing 1745 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death. Distribution is nationwide and the recall remains in progress.

Product

Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.

Lot / code: Lot #:14218, Exp. Date 08/2022

Quantity: 32,544 glass bottles

Reason for recall

Superpotent Drug

Recall record

Recall number: D-0800-2021
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States and Canada
Recall initiated: 2021-08-03
Classified by FDA Center: 2021-09-15
FDA published: 2021-09-22
Recalling firm: Teligent Pharma, Inc.
Firm location: Buena, NJ

Operational response

A Class I recall indicates a strong likelihood of serious adverse health consequence or death. Pull affected lots from active dispensing immediately. Segregate inventory in a marked, locked location pending destruction or return. If product has already been dispensed, identify affected patients and contact them by your standard recall-notification protocol.

For the official FDA enforcement record, see FDA's Recall Search.

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