INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Reported: December 5, 2018 Initiated: November 8, 2018 #D-0282-2019
Product Description
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
Reason for Recall
Failed Stability Specification: out of specification for iron content.
Details
- Recalling Firm
- ALLERGAN
- Units Affected
- 111,132 cartons/10 vials per carton
- Distribution
- Product was distributed throughout the United States.
- Location
- Madison, NJ
Frequently Asked Questions
What product was recalled? ▼
INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL), Rx only, packaged in 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07. Recalled by ALLERGAN. Units affected: 111,132 cartons/10 vials per carton.
Why was this product recalled? ▼
Failed Stability Specification: out of specification for iron content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 5, 2018. Severity: Moderate. Recall number: D-0282-2019.
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