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Recall Observatory FDA recall evidence

Drug product

Econazole Nitrate Cream 1%, 85 grams bulk shippers, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-022-85 ; packaged in tubes.

D-0751-2021

July 19, 2021

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 88293
Status
Terminated
Classification
Class II
Quantity
14688 tubes
Official record key
drug-enforcement:D-0751-2021

Official wording

Reason: Correct Labeled Product Mispack

Code information: Lot # 16630; Exp 03/2023

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Correct Labeled Product Mispack