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Class II: temporary or reversible health riskTerminated

Shilpa Medicare Busulfan Injection 60 mg/10 mL Recall

Busulfan Injection 60 mg/10 mL (6 mg/mL), For Intravenous Infusion Only, Must be dilute…

Shilpa Medicare Limited · Polepally, Jadcherla, N/A

Risk level
Class II
Reported by FDA
Dec 16, 2020
Recall ID
D-0121-2021
Check your lot numberHow we source this data

Summary

Shilpa Medicare recalled Busulfan Injection 60 mg/10 mL starting Dec 8, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0121-2021 on Dec 16, 2020. Reason: CGMP Deviations. Status: Terminated.

Why it was recalled

CGMP Deviations

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.

Lot numbers, UPCs & expiration codes

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

Where it was sold

Nationwide in the U.S.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0121-2021
Classification
Class II
Status
Terminated
Recall initiated
Dec 8, 2020
FDA report date
Dec 16, 2020
Quantity
2,064 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Shilpa Medicare Limited

Original FDA data

Every field from FDA enforcement report D-0121-2021, exactly as published.

Show all FDA fields
City
Polepally, Jadcherla
Status
Terminated
Country
India
Event ID
86749
Address
S-20 To S-26, Pharm. Formulation Sez
Address (line 2)
Tsiic, Green Industrial Park
Code information
Lot #: 7S10008B, Exp. 12/31/2020
Report date
Dec 16, 2020
Product type
Drugs
Recall number
D-0121-2021
Classification
Class II
Recalling firm
Shilpa Medicare Limited
Product quantity
2,064 vials
Termination date
Mar 11, 2022
Reason for recall
CGMP Deviations
Voluntary / mandated
Voluntary: Firm initiated
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.
Distribution pattern
Nationwide in the U.S.
Recall initiation date
Dec 8, 2020
Initial firm notification
Letter
Center classification date
Dec 9, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0121-2021, published Dec 16, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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