Hospira Recalls Dacarbazine Injection Vials Due to Discoloration
Hospira Inc. is recalling 3,306 vials of Dacarbazine Injection, USP, 200mg, because the reconstituted solution may appear pink instead of the expected colorless to pale yellow.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which by definition is unlikely to cause adverse health consequences. The issue is a cosmetic discoloration without reported injuries or illnesses.
Plain-English summary
Hospira Inc. is recalling 3,306 vials of Dacarbazine, Injection, USP, 200mg, packaged in individual cartons. The product is prescription-only and was manufactured by Hospira Australia. The specific lot number is B032223AA, with an expiration date of July 2016. The recall is distributed nationwide.
The recall was initiated due to a discoloration issue. When the solution is reconstituted and stored according to labeled conditions, it may appear pink instead of the expected colorless to pale yellow appearance. The FDA has classified this recall as Class III, indicating that use of or exposure to the product is not likely to cause adverse health consequences.
Healthcare providers and patients should discontinue use of the affected vials and contact Hospira Inc. for further instructions or a replacement. Consumers should not use the product if the solution appears pink upon reconstitution.
The recalled product
- Product
- 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.
- Manufacturer
- Hospira Inc.
- Category
- Drug — Injection
- Hazard
- Affected units
- 3,306
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 #: B032223AA
- Exp: July 2016
Distribution
Distributed nationwide across the United States.
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