Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count Bottle, Manufactured by: Shilpa Medicare Limi...
FDA Recall #D-0124-2021 — Class II — December 8, 2020
Product Description
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.
Reason for Recall
CGMP Deviations
Recalling Firm
Shilpa Medicare Limited — Polepally, Jadcherla, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2611 bottles
Distribution
Nationwide in the U.S.
Code Information
Lot #s: 7S10033B, 7S10033A, 7S10031A, Exp. 02/28/2021.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated