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Class III: unlikely to cause harmTerminated

Hospira Dacarbazine Recall

Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Man…

Hospira Inc. · Lake Forest, IL

Risk level
Class III
Reported by FDA
Dec 31, 2014
Recall ID
D-0313-2015
Check your lot numberHow we source this data

Summary

Hospira recalled Dacarbazine starting Nov 25, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0313-2015 on Dec 31, 2014. Reason: Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions. Status: Terminated.

Why it was recalled

Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.

Product description

Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.

Lot numbers, UPCs & expiration codes

Lot #: B032223AA; Exp: July 2016

Where it was sold

Nationwide

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-0313-2015
Classification
Class III
Status
Terminated
Recall initiated
Nov 25, 2014
FDA report date
Dec 31, 2014
Quantity
3,306 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Hospira Inc.

Original FDA data

Every field from FDA enforcement report D-0313-2015, exactly as published.

Show all FDA fields
City
Lake Forest
State
IL
Status
Terminated
Country
United States
Event ID
69900
Address
275 N Field Dr
Code information
Lot #: B032223AA; Exp: July 2016
Postal code
60045-2579
Report date
Dec 31, 2014
Product type
Drugs
Recall number
D-0313-2015
Classification
Class III
Recalling firm
Hospira Inc.
Product quantity
3,306 vials
Termination date
Dec 15, 2016
Reason for recall
Discoloration: Reconstituted solution may appear pink instead of colorless to pale yellow when stored per the labeled conditions.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Dacarbazine, Injection, USP, 200mg, vials packaged in individual cartons, Rx only, Manufactured by Hospira Australia 1 Lexia Place, Mulgrave, Victoria Australia 3170. NDC 61703-327-22.
Distribution pattern
Nationwide
Recall initiation date
Nov 25, 2014
Initial firm notification
Letter
Center classification date
Dec 22, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0313-2015, published Dec 31, 2014. 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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