Recalls / Class I
Class ID-0324-2015
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.9% Sodium Chloride Injection, 500 mL flexible container unit, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-7620-03
- Brand name
- Heparin Sodium
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous
- NDCs
- 0409-1005, 0409-7620, 0409-2222
- FDA application
- NDA018916
- Affected lot / code info
- Lot #: 41-046-JT, Exp 11/01/2015
Why it was recalled
Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between the tube and film at the round seal of the unused administrative port of the container.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 63,378 flexible container units
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-09-11
- FDA classified
- 2014-12-23
- Posted by FDA
- 2014-12-31
- Terminated
- 2016-01-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0324-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.