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Recall Observatory FDA recall evidence

Drug product

Gentamicin Sulfate Cream USP, 0.1%, packaged in a) 15 g tubes, NDC 52565-085-15, b) 30 g tubes, NDC 52565-085-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310.

D-0686-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
355,672 tubes
Official record key
drug-enforcement:D-0686-2022

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) 15342, 15343, 16686, Exp. 3/31/2023; b) 15259, 15260, Exp. 3/31/2022; 15282, Exp. 4/30/2022; 15283, Exp. 5/31/2022; 15725, 15745, 15764, Exp. 6/30/2022; 16066, Exp. 10/31/2022

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