FDA-Drug2020-12-16Class II
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.
Shilpa Medicare Limited
Hazard
CGMP Deviations
Sold states
Nationwide in the U.S.
Affected count
4166 bottles
Manufactured in
S-20 To S-26, Pharm. Formulation Sez, Tsiic, Green Industrial Park, Polepally, Jadcherla, N/A, India
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0125-2021Don't want to check this manually?
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