Recalls / Class II
Class IID-0418-2015
Product
Ketamine Hydrochloride Injection, USP (100 mg/mL) packaged in 5 mL multi-dose glass fliptop vials, 10 vials per box, Rx only, Manufactured by: Hospira Inc., Lake Forest, IL 60045. NDC 00409-2051-05
- Affected lot / code info
- Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016
Why it was recalled
Defective Container: There were customer complaints of cracked and leaking glass vials.
Recalling firm
- Firm
- Hospira Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 275 N Field Dr, Lake Forest, Illinois 60045-2579
Distribution
- Quantity
- 83,320 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-08-20
- FDA classified
- 2015-09-15
- Posted by FDA
- 2015-09-23
- Terminated
- 2017-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0418-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.