Recalls / Class III
Class IIID-0001-2018
Product
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.
- Affected lot / code info
- Lot: 51275DD; Exp. 09/01/17
Why it was recalled
CGMP Deviations: Firm failed to control impurity for color change at the API stage.
Recalling firm
- Firm
- Pfizer Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 235 E 42nd St, N/A, New York, New York 10017-5703
Distribution
- Quantity
- 32,276 10 mL vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2017-07-12
- FDA classified
- 2017-10-03
- Posted by FDA
- 2017-10-11
- Terminated
- 2020-07-16
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0001-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.