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.
Product description
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
Lot numbers, UPCs & expiration codes
Lot # 27-352-DK; Exp 03/15
Where it was sold
Nationwide and Puerto Rico.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1540-2014
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Jan 10, 2014
- FDA report date
- Aug 27, 2014
- Quantity
- 123,900 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1540-2014, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 67354
- Address
- 375 N Field Dr
- Code information
- Lot # 27-352-DK; Exp 03/15
- Postal code
- 60045-2513
- Report date
- Aug 27, 2014
- Product type
- Drugs
- Recall number
- D-1540-2014
- Classification
- Class I
- Recalling firm
- Hospira Inc.
- Product quantity
- 123,900 vials
- Termination date
- Jul 14, 2015
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Jan 10, 2014
- Initial firm notification
- Letter
- Center classification date
- Aug 18, 2014