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Recall Observatory FDA recall evidence

Drug product

Desoximetasone Ointment USP, 0.25%, packaged in a) 100 grams tubes, NDC 52565-030-99; b) 60 grams tubes, NDC 52565-030-60; c) 15 grams tubes, NDC 52565-030-15, Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0678-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
13,989 tubes
Official record key
drug-enforcement:D-0678-2022

Official wording

Reason: cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

Code information: Batch: a) 15496, Exp. 4/30/2022; 16347, Exp. 1/31/2023; b) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023; c) 15496, Exp. 4/30/2022; 16298, Exp. 1/31/2023

Distribution pattern: Nationwide in the USA and Puerto Rico

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations