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Recall Observatory FDA recall evidence

Drug product

Betamethasone Dipropionate Lotion USP, 0.05%* (Augmented), packaged in a) 30 mL (29 grams) bottles, NDC 52565-023-29; b) 60 mL (58 grams) bottles, NDC 52565-023-59, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310

D-0669-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
43,218 bottles
Official record key
drug-enforcement:D-0669-2022

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) 15998, Exp. 3/31/2022; b) 16104, Exp. 4/30/2022; 16133, Exp. 5/31/2022; 16391, Exp. 8/31/2022; 15440, Exp. 9/30/2022

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