Hospira Inc.: Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx on

Is my product affected?

Carboplatin Injection, 10 mg/mL, a) 5 mL multi-dose vials (NDC 61703-339-18) (NDC 61703-360-18, NOVAPLUS), b) 45 mL multi-dose vials (NDC 61703-339-50) (NDC 61703-360-50 NOVAPLUS), Rx only, Hospira, Inc., Lake Forest, IL 60045, Product of Australia

• Brand CARBOPLATIN

Check against the official notice below — it lists the full affected range.

What happened

Hospira Inc. is recalling Carboplatin Injection in multiple vial sizes and formulations distributed nationwide and in Puerto Rico. The recall affects 77,542 vials across several lot numbers with various expiration dates ranging from December 2012 to April 2013. The reason for the recall is that the carboplatin injection lots were manufactured from active pharmaceutical ingredient lots that had pH levels that trended below specification.

The specific affected products include 5 mL multi-dose vials under NDC 61703-339-18 (lot Y031654AB) and NDC 61703-360-18 (lot Y031654AA), as well as 45 mL multi-dose vials under NDC 61703-339-50 (lot numbers Y041711AA and Y061711AB) and NDC 61703-360-50 (lot Y061711AA). The source document does not specify a remedy or recommended action for affected consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH.

Details from the source

Reason for recall: Failed PH specification: The lots of Carboplatin Injection were manufactured from Carboplatin API lots which trended out of specification low pH. Distribution: Nationwide and Puerto Rico Quantity: 77,542 vials Lot/code info: 5 mL vial - NDC 61703-339-18 (Hospira label), lot number Y031654AB, expiration APR2013; NDC 61703-360-18 (Novoplus label), lot number Y031654AA, expiration APR2013; 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, expiration FEB 2013

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

Related recalls

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All FDA (Drug enforcement) recalls