Hospira Recalls Carboplatin Injection Vials Due to pH Specification Failure
Hospira Inc. is recalling 77,542 vials of Carboplatin Injection because the active ingredient lots trended out of specification for low pH.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The source text identifies this as an FDA Class III recall, which the rubric defines as typically scoring 1 or 2 because it is unlikely to cause adverse health consequences.
Plain-English summary
Hospira Inc. is recalling 77,542 vials of Carboplatin Injection, 10 mg/mL, in 5 mL and 45 mL multi-dose vial sizes. The affected products are distributed nationwide and in Puerto Rico. The recall includes specific lot numbers and expiration dates ranging from December 2012 to April 2013, associated with NDC codes 61703-339 and 61703-360.
The recall was initiated because the Carboplatin Injection lots were manufactured from Carboplatin API lots that trended out of specification for low pH. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Healthcare providers and patients should discontinue use of the affected lots and return them to the distributor or manufacturer. Consumers should check their medication vials against the specific lot numbers and expiration dates listed in the official recall notice to determine if they are affected.
The recalled product
- Product
- CARBOPLATIN (CARBOPLATIN)
- Brand
- CARBOPLATIN
- Manufacturer
- Hospira Inc.
- Category
- Drug — Antineoplastic
- Hazard
- Affected units
- 77,542
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 (11)
- 5 mL vial - NDC 61703-339-18 (Hospira label)
- lot number Y031654AB
- expiration APR2013
- NDC 61703-360-18 (Novoplus label)
- lot number Y031654AA
- 45 mL vial - NDC 61703-339-50 (Hospira label)
- lot numbers Y041711AA
- expiration DEC 2012 and Y061711AB
- expiration FEB 2013
- NDC 61703-360-50 (Novoplus label)
- lot number Y061711AA
Distribution
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