FDA Drug Class II — Moderate

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.

Hazard

CGMP Deviations

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Products

Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals Inc., Manalapan, NJ 07726, NDC 72485-202-90.
Brand
Shilpa Medicare Limited
UPC
Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.

Units Affected

2611 bottles

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