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Recall Observatory FDA recall evidence

Drug product

Mometasone Furoate Cream, 0.1%, 45 g tube, Rx Only, Manufactured by: G&W Laboratories, Inc. South Plainfield, NJ 07080, NDC 0713-0726-37

D-0514-2019

February 07, 2019

Class III

Product summary

Firm
ACP Nimble Buyer, Inc.
Event
Event 80878
Status
Terminated
Classification
Class III
Quantity
58,176 units
Official record key
drug-enforcement:D-0514-2019

Official wording

Reason: Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.

Code information: Lot #: 1009431, 1009507, Exp. 08/2020; 1009886, Exp. 09/2020

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Not Elsewhere Classified. Mometasone Furoate Cream has an NDC typographical error.