The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0125-2021·Announced 2020-12-16

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.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 →

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