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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-0296-2022

November 30, 2021

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89135
Status
Ongoing
Classification
Class II
Quantity
7,176 bottles
Official record key
drug-enforcement:D-0296-2022

Official wording

Reason: Superpotent Drug: Minimally superpotent

Code information: Lot #: 15594, Exp Date 05/2023

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