FDA Recall D-0296-2022

Teligent Pharma, Inc. · Buena, NJ

Class II Ongoing 1626 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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 #: 15594, Exp Date 05/2023

Quantity: 7,176 bottles

Reason for recall

Superpotent Drug: Minimally superpotent

Recall record

Recall number: D-0296-2022
Classification: Class II
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

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

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

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