Drug product
DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02
D-1540-2014
Product summary
- Firm
- Hospira Inc.
- Event
- Event 67354
- Status
- Terminated
- Classification
- Class I
- Quantity
- 123,900 vials
- Official record key
drug-enforcement:D-1540-2014
Official wording
Reason: Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution.
Code information: Lot # 27-352-DK; Exp 03/15
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Foreign material or chemical contamination
Particulate Matter