Recalls / Class II
Class IID-0125-2021
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.
- Brand name
- Imatinib Mesylate
- Generic name
- Imatinib Mesylate
- Active ingredient
- Imatinib Mesylate
- Route
- Oral
- NDC
- 72485-203
- FDA application
- ANDA208302
- Affected lot / code info
- Lot #s: 7S10032A, 7S10034A, Exp. 02/28/2021
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Shilpa Medicare Limited
- Manufacturer
- Armas Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- S-20 To S-26, Pharm. Formulation Sez, Tsiic, Green Industrial Park, Polepally, Jadcherla, N/A N/A, India
Distribution
- Quantity
- 4166 bottles
- Distribution pattern
- Nationwide in the U.S.
Timeline
- Recall initiated
- 2020-12-08
- FDA classified
- 2020-12-09
- Posted by FDA
- 2020-12-16
- Terminated
- 2022-03-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0125-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.