INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Reported: March 7, 2018 Initiated: December 13, 2017 #D-0545-2018
Product Description
INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Reason for Recall
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Details
- Recalling Firm
- ALLERGAN
- Units Affected
- 163,694 cartons
- Distribution
- Product was distributed nationwide in the USA.
- 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 a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.. Recalled by ALLERGAN. Units affected: 163,694 cartons.
Why was this product recalled? ▼
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 7, 2018. Severity: Moderate. Recall number: D-0545-2018.
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