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Recall Observatory FDA recall evidence

Drug product

Diflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured for: SOLA Pharmaceuticals, LLC Baton Rouge, LA 70809, NDC 70512-031-60.

D-0681-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
24,304 bottles
Official record key
drug-enforcement:D-0681-2022

Official wording

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

Code information: Batch: 15800, Exp. 7/31/2022; 15876, 15904, 15917, 15922, Exp. 8/31/2022; 16202, 16203, Exp. 11/30/2022.

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