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Recall Observatory FDA recall evidence

Drug product

Econazole Nitrate Cream, 1%, packaged in a) 15 grams tubes, NDC 52565-022-15; b) 85 grams tubes, NDC 52565-022-85; c) 30 grams tubes, NDC 52565-022-30, Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, New Jersey 08310.

D-0682-2022

March 15, 2022

Class II

Product summary

Firm
Teligent Pharma, Inc.
Event
Event 89798
Status
Terminated
Classification
Class II
Quantity
151,975 tubes
Official record key
drug-enforcement:D-0682-2022

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) 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; b) 15349, Exp. 2/28/2022; 16410, 16438, Exp. 1/31/2023; 16882, Exp. 4/30/2023; c) 16410, 16438, Exp. 1/31/2023

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