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Recall Observatory FDA recall evidence

Drug product

Fluocinonide Topical Solution USP, 0.05%, packaged in a) 20 mL bottles, NDC 52565-025-20; b) 60 mL bottles, NDC 52565-025-59, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0685-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
7169 bottles
Official record key
drug-enforcement:D-0685-2022

Official wording

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

Code information: Batch: 17138, Exp. 2/28/2023

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