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Recall Observatory FDA recall evidence

Drug product

(Malin+Goetz) spf 30 face moisturizer (Avobenzone 3%, Homosalate 10 %, Octinoxate 7.5%, Octisalate 2.75%, Oxybenzone 5%) 1.7 fl. oz. 50 ml tubes, Distributed by: Malin+Goetz Inc 330 Seventh Avenue, New York, New York, 10001

D-0090-2021

October 09, 2020

Class II

Product summary

Firm
Milbar Laboratories, Inc.
Event
Event 86579
Status
Terminated
Classification
Class II
Quantity
3,692 tubes
Official record key
drug-enforcement:D-0090-2021

Official wording

Reason: GMP Deviations

Code information: Lot #: AW761-9, Exp. Date Jan-22

Distribution pattern: Product was distributed throughout the United States, including Puerto Rico and internationally.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    GMP Deviations