Skip to content
Recall Observatory FDA recall evidence

Drug product

Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50

D-0280-2022

October 12, 2021

Class I

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 88850
Status
Terminated
Classification
Class I
Quantity
52,104 glass bottles
Official record key
drug-enforcement:D-0280-2022

Official wording

Reason: Superpotent Drug

Code information: Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent