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Recall Observatory FDA recall evidence

Drug product

Flurandrenolide Ointment USP, 0.05%, Net Wt. 60 grams, Rx Only, Teligent Pharma, Inc. Buena, New Jersey 08310 NDC 52565-017-60

D-0356-2021

April 09, 2021

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 87694
Status
Ongoing
Classification
Class II
Quantity
3432 tubes
Official record key
drug-enforcement:D-0356-2021

Official wording

Reason: Failed Impurities/Degradation Specifications:

Code information: Lot #13974 EXP 7/2021

Distribution pattern: Distributed Nationwide in the USA

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Impurities/Degradation Specifications