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Recall Observatory FDA recall evidence

Drug product

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

D-0690-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
6431 bottles
Official record key
drug-enforcement:D-0690-2022

Official wording

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

Code information: Batch: 15435, Exp. 3/31/2022; 16960, Exp. 5/31/2023

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