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Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II),...

FDA Recall #D-0294-2015 — Class II — December 3, 2014

Recall #D-0294-2015 Date: December 3, 2014 Classification: Class II Status: Terminated

Product Description

Fentanyl Citrate Injection, USP, 2500 mcg Fentanyl/50 mL, 50 mL Single-dose Flip top Vial (C-II), Rx only, 25 units per box/50 units per case, Hospira Inc., Lake Forest, IL --- NDC 0409-9094-61

Reason for Recall

Lack of Assurance of Sterility; improperly crimped fliptop vials

Recalling Firm

Hospira Inc. — Lake Forest, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

62,650 vials

Distribution

Nationwide

Code Information

Lot 41-099-DK, exp 01MAY2016, NDC 0409-9094-61

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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