FDA Recall D-0295-2022

Teligent Pharma, Inc. · Buena, NJ

Class I — life-threatening Ongoing 1626 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% (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

Lot / code: Lot #: 16345, Exp. Date 01/2024

Quantity: 6,816 bottles

Reason for recall

Superpotent Drug

Recall record

Recall number: D-0295-2022
Classification: Class I
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Distributed to a wholesaler in CO who further distributed Nationwide in the USA
Recall initiated: 2021-11-30
Classified by FDA Center: 2021-12-28
FDA published: 2022-01-05
Recalling firm: Teligent Pharma, Inc.
Firm location: Buena, NJ

Drug identification

Brand name(s): LIDOCAINE HYDROCHLORIDE
Generic name(s): LIDOCAINE HYDROCHLORIDE
Manufacturer(s): McKesson Corporation dba SKY Packaging
NDC(s): 63739-997
Route(s): TOPICAL

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.

‹ All recalls