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.
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. 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 07726,
- 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.
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