FDA Recalls Imatinib Mesylate Tablets Due to Manufacturing Deviations
Shilpa Medicare Limited is recalling 4,166 bottles of Imatinib Mesylate 400 mg tablets nationwide due to Current Good Manufacturing Practice (CGMP) deviations.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. According to the rubric, an FDA Class II recall is assigned a severity score of 4 (Severe), as it may cause temporary or medically reversible adverse health consequences.
Plain-English summary
Shilpa Medicare Limited is voluntarily recalling 4,166 bottles of Imatinib Mesylate Tablets 400 mg, 30-count bottles. The product is distributed by Armas Pharmaceuticals Inc. in Manalapan, New Jersey, and was available nationwide in the United States. The specific lots affected are 7S10032A and 7S10034A, both with an expiration date of 02/28/2021. The NDC for the product is 72485-203-30.
The recall was initiated because of Current Good Manufacturing Practice (CGMP) deviations. The FDA has classified this recall as Class II, which indicates that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall was initiated on December 8, 2020, and was terminated on March 11, 2022.
The recalled product
- Product
- IMATINIB MESYLATE (IMATINIB MESYLATE)
- Brand
- IMATINIB MESYLATE
- Manufacturer
- Shilpa Medicare Limited
- Category
- Drug — Prescription Drug
- Hazard
- Affected units
- 4,166
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #s: 7S10032A
- 7S10034A
- Exp. 02/28/2021
UPCs (1)
- 0372485203307
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Shilpa Medicare Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 6 products in this recall →Related recalls
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