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.
Reported: December 16, 2020 Initiated: December 8, 2020 #D-0124-2021
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
Details
- Recalling Firm
- Shilpa Medicare Limited
- Units Affected
- 2611 bottles
- Distribution
- Nationwide in the U.S.
- Location
- Polepally, Jadcherla, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Shilpa Medicare Limited. Units affected: 2611 bottles.
Why was this product recalled? ▼
CGMP Deviations
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 16, 2020. Severity: Moderate. Recall number: D-0124-2021.
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