Why it was recalled
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Product description
Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
Lot numbers, UPCs & expiration codes
Lot: 51275DD; Exp. 09/01/17
Where it was sold
Nationwide
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-0001-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 12, 2017
- FDA report date
- Oct 11, 2017
- Quantity
- 32,276 10 mL vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Pfizer Inc.
Original FDA data
Every field from FDA enforcement report D-0001-2018, exactly as published.
Show all FDA fields
- City
- New York
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 77731
- Address
- 235 E 42nd St
- Code information
- Lot: 51275DD; Exp. 09/01/17
- Postal code
- 10017-5703
- Report date
- Oct 11, 2017
- Product type
- Drugs
- Recall number
- D-0001-2018
- Classification
- Class III
- Recalling firm
- Pfizer Inc.
- Product quantity
- 32,276 10 mL vials
- Termination date
- Jul 16, 2020
- Reason for recall
- CGMP Deviations: Firm failed to control impurity for color change at the API stage.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Deferoxamine Mesylate for injection, USP, Single-use Vial, 500 mg/vial, 10 mL vial. Intravenous, Intramuscular, Subcutaneous Use, Rx Only, Hospira, Inc., Lake Forest IL USA, NDC 0406-2336-10.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 12, 2017
- Initial firm notification
- Letter
- Center classification date
- Oct 3, 2017