Drug 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
D-0418-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 71939
- Status
- Terminated
- Classification
- Class II
- Quantity
- 83,320 vials
- Official record key
drug-enforcement:D-0418-2015
Official wording
Reason: Defective Container: There were customer complaints of cracked and leaking glass vials.
Code information: Lot #s: 43406DD, Exp 7/1/2016; 44255DD, Exp 8/1/2016
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Container: There were customer complaints of cracked and leaking glass vials.