Imatinib Mesylate Tablets 400 mg, Rx Only, 30-count Bottle, Manufactured by: Shilpa Medicare Limi...
FDA Recall #D-0125-2021 — Class II — December 8, 2020
Product Description
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.
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
4166 bottles
Distribution
Nationwide in the U.S.
Code Information
Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated