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Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be diluted before u...

FDA Recall #D-0121-2021 — Class II — December 8, 2020

Recall #D-0121-2021 Date: December 8, 2020 Classification: Class II Status: Terminated

Product Description

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, Vial NDC 72485-210-01, Carton NDC 72485-210-08.

Reason for Recall

CGMP Deviations

Recalling Firm

Shilpa Medicare Limited — Polepally, Jadcherla, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

2,064 vials

Distribution

Nationwide in the U.S.

Code Information

Lot #: 7S10008B, Exp. 12/31/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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