Recall: D-0125-2021

Class II - Potentially Harmful

Class IIClassification

2020-12-08Initiated

TerminatedStatus

Shilpa Medicare LimitedFirm

Product

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

CGMP Deviations

Distribution

Nationwide in the U.S.

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.