FDAFDA · Food and drugs·Recall number D-0125-2021
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.
Published December 16, 2020 · Recall initiated: December 8, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- IMATINIB MESYLATE
- Manufacturer
- Shilpa Medicare Limited
- Distributor
- Nationwide in the U.S.
- UPC
- 0372485203307
- Lot
- Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- India
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