The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0124-2021·Announced 2020-12-16

Shilpa Medicare Recalls Imatinib Mesylate Tablets Due to Manufacturing Deviations

Shilpa Medicare Limited is voluntarily recalling 2,611 bottles of Imatinib Mesylate 100 mg tablets 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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II due to CGMP deviations, which typically indicates a remote probability of serious adverse health consequences, aligning with the Moderate severity criteria for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Shilpa Medicare Limited has initiated a voluntary recall of Imatinib Mesylate Tablets 100 mg, Rx Only, 90-count bottles. The recall involves 2,611 bottles distributed nationwide in the U.S. by Armas Pharmaceuticals Inc. The affected lots are 7S10033B, 7S10033A, and 7S10031A, all with an expiration date of 02/28/2021. The product is identified by NDC 72485-202-90.

The recall was initiated due to 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.

Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for disposal or replacement. 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
2,611

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 (4)

  • Lot #s: 7S10033B
  • 7S10033A
  • 7S10031A
  • Exp. 02/28/2021.

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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