The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0121-2021·Announced 2020-12-16

Shilpa Medicare Recalls Busulfan Injection Due to Manufacturing Deviations

Shilpa Medicare Limited is voluntarily recalling 2,064 vials of Busulfan Injection due to CGMP deviations. The recall is nationwide and the lot expired in December 2020.

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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving significant injury/property-damage reports or structural defects, though here it is a drug recall with CGMP deviations.

Plain-English summary

Shilpa Medicare Limited is voluntarily recalling 2,064 vials of Busulfan Injection 60 mg/10 mL (6 mg/mL). The product is a sterile, cytotoxic agent intended for intravenous infusion only and must be diluted before use. The specific lot number is 7S10008B, with an expiration date of 12/31/2020. The product was distributed nationwide in the U.S. by Armas Pharmaceuticals, Inc.

The recall was initiated because of 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 was initiated on December 8, 2020, and was terminated on March 11, 2022.

Healthcare providers and patients should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the distributor or recalled firm according to their instructions. No illnesses or injuries have been reported in the source text.

The recalled product

Product
Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before use, Single Dose Vial, Sterile, Cytotoxic Agent, Rx Only, 10 mL vial, Manufactured by: Shilpa Medicare Limited, India, Distributed by: Armas Pharmaceuticals, Inc., Manalapan, NJ…
Manufacturer
Shilpa Medicare Limited
Category
Drug — Injection
Hazard
Affected units
2,064

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 #: 7S10008B
  • Exp. 12/31/2020

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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