Recalls / Class I
Class ID-1540-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
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
- Brand name
- Dobutamine
- Generic name
- Dobutamine
- Active ingredient
- Dobutamine Hydrochloride
- Route
- Intravenous
- NDC
- 0409-2344
- FDA application
- ANDA074086
- Affected lot / code info
- Lot # 27-352-DK; Exp 03/15
Why it was recalled
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.
Recalling firm
- Firm
- Hospira Inc.
- Manufacturer
- Hospira, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 375 N Field Dr, Lake Forest, Illinois 60045-2513
Distribution
- Quantity
- 123,900 vials
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2014-01-10
- FDA classified
- 2014-08-18
- Posted by FDA
- 2014-08-27
- Terminated
- 2015-07-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1540-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.