Why it was recalled
Discoloration: Firm received complaints of product discoloration and particulates.
Product description
DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
Lot numbers, UPCs & expiration codes
Lot #: 52175DD, Exp 01 Oct 2016
Where it was sold
Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
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-1500-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 15, 2016
- FDA report date
- Sep 21, 2016
- Quantity
- 24000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-1500-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 74707
- Address
- 275 N Field Dr
- Code information
- Lot #: 52175DD, Exp 01 Oct 2016
- Postal code
- 60045-2579
- Report date
- Sep 21, 2016
- Product type
- Drugs
- Recall number
- D-1500-2016
- Classification
- Class II
- Recalling firm
- Hospira Inc.
- Product quantity
- 24000 vials
- Termination date
- Aug 23, 2019
- Reason for recall
- Discoloration: Firm received complaints of product discoloration and particulates.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- DOBUTamine Injection, USP 250 mg/20 mL, 20 mL Vial, For IV Use Only, Must be Diluted Prior to Use, (12.5 mg per mL), Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-2025-20
- Distribution pattern
- Product was distributed nationwide. 23700 units distributed to US and Puerto Rico, and Bahamas was 300 units. 30 units returned by customer and destroyed internally.
- Recall initiation date
- Aug 15, 2016
- Initial firm notification
- Letter
- Center classification date
- Sep 14, 2016