FDA Drug Class II — Moderate

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.

Hazard

CGMP Deviations

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Products

Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-203-30.
Brand
Shilpa Medicare Limited
UPC
Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021

Units Affected

4166 bottles

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