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Recall Observatory FDA recall evidence

Drug product

Econazole Nitrate Cream, 1%, Generic for Spectazole, 30 gm tube, Rx Only, Preferred Pharmaceuticals, Inc., The Physican's Solution, Mfg: Teligent Pharma, Inc., NDC 68788-7406-03

D-0771-2022

March 24, 2022

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 89943
Status
Terminated
Classification
Class II
Quantity
41 Tubes
Official record key
drug-enforcement:D-0771-2022

Official wording

Reason: CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.

Code information: Lot #: A1122P, G1421N, Exp. 1/1/2023

Distribution pattern: Product distributed in California and Florida.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations