FDA recall D-0124-2021
Shilpa Medicare Limited · Class II · drug
Product
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
Distribution
Nationwide in the U.S.
Key facts
- Status
- Terminated
- Initiation date
- 2020-12-08
- Report date
- 2020-12-16
- Termination date
- 2022-03-11
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Polepally, Jadcherla, N/A, India
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0124-2021