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Recall Observatory FDA recall evidence

Drug product

Clobetasol Propionate Ointment USP 0.05%, Net Wt. 50 grams, Rx Only, Teligent Pharma. Inc. Buena, NJ 08310 NDC 52565-039-60

D-0119-2021

November 05, 2020

Class III

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 86714
Status
Terminated
Classification
Class III
Quantity
20160 tubes
Official record key
drug-enforcement:D-0119-2021

Official wording

Reason: Superpotent and Subpotent; low and high assay results

Code information: Lot Number: 12597, exp. date 12/2020

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Superpotent