Recalls / Class II
Class IID-618-2013
Product
1.5% Glycine Irrigation, USP, 3000 mL, Rx Only, Hospira, Inc., Lake Forest, IL 60045 NDC 0409-7974-08
- Affected lot / code info
- Lot #: 95-057-JT, Exp 11/12
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
- 40,988 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-618-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.