Recalls / Class II
Class IID-616-2013
Product
20% Dextrose Injection, USP, a) 500 mL in 1000 mL Partial-Fill Container (NDC 0409-7935-19), b) 500 mL VisIV Container (NDC 0409-7953-30), c) 1000 mL VisIV Container, (NDC 0409-7953-48), Rx Only, Hospira, Inc., Lake Forest, IL 60045
- Affected lot / code info
- Lot #: a) 09-183-JT, Exp 3/13; b) 01-081-JT, Exp 7/12; c) 07-078-JT, 91-083-JT, Exp 7/12
Why it was recalled
Lack of Assurance of Sterility: Hospira, Inc is voluntarily recalling the products due to possible leaking bags.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 216,396 units
- Distribution pattern
- Nationwide Puerto Rico, U.S. Virgin Island, Libya, Saudi Arabia
Timeline
- Recall initiated
- 2012-05-04
- FDA classified
- 2013-06-21
- Posted by FDA
- 2013-07-03
- Terminated
- 2015-07-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-616-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.