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Recall Observatory FDA recall evidence

Drug 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

D-0295-2022

November 30, 2021

Class I

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89135
Status
Ongoing
Classification
Class I
Quantity
6,816 bottles
Official record key
drug-enforcement:D-0295-2022

Official wording

Reason: Superpotent Drug

Code information: Lot #: 16345, Exp. Date 01/2024

Distribution pattern: Distributed to a wholesaler in CO who further distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent