The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0123-2021·Announced 2020-12-16

Shilpa Medicare Recalls Azacitidine Injection Vials Due to Manufacturing Deviations

Shilpa Medicare Limited is recalling 6,560 vials of Azacitidine for Injection due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and nationwide.

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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for adverse health consequences are mapped to a severity score of 4 (Severe), as they are not Class I (Critical) but involve more than minor labeling errors.

Plain-English summary

Shilpa Medicare Limited is voluntarily recalling 6,560 vials of Azacitidine for Injection 100 mg/vial. The product is a prescription-only cytotoxic agent intended for subcutaneous and intravenous use. It was manufactured by Shilpa Medicare Limited in India and distributed by Armas Pharmaceuticals, Inc., in Manalapan, NJ. The specific lot affected is 7S10227A, with an expiration date of 10/31/2021.

The recall was initiated on December 8, 2020, due to Current Good Manufacturing Practice (CGMP) deviations. The FDA classified this recall as Class II, which indicates a situation where 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. The recall status is currently terminated as of March 11, 2022.

The affected product was distributed nationwide in the U.S. Patients and healthcare providers should check their inventory for the specific lot number 7S10227A. If the product is found, it should be quarantined and not administered. For further information, contact the recalling firm or the FDA.

The recalled product

Product
Azacitidine for Injection 100 mg/vial, For Subcutaneous and Intravenous Use Only, Rx Only, One Single Dose Vial, Cytotoxic Agent, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ 07726, NDC 72606-558-01.
Manufacturer
Shilpa Medicare Limited
Category
Drug — Injection
Hazard
Affected units
6,560

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 (2)

  • Lot #: 7S10227A
  • Exp. 10/31/2021

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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