Why it was recalled
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
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.
Lot numbers, UPCs & expiration codes
Lot# 15W05A, Exp.FEB-2018; 16W02A, Exp. DEC 2018; 16W05A, Exp. JAN-2019; 16W13A, Exp. APR-2019; 16W15A, 16W16A, 16W17A, Exp. MAY 2019; 16W18A, Exp. JUN 2019; 16W20A, 16W22A, Exp. SEP 2019; 17W01A, 17W02A, Exp. DEC-2019; 17W04A, 17W05A, Exp. JAN 2020; 17W09A, Exp. MAR-2020; 17W11A, 17W13A, Exp. MAY 2020; 17W14A, 17W15A, Exp. JUN 2020
Where it was sold
Product was distributed nationwide in the USA.
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-0545-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 13, 2017
- FDA report date
- Mar 7, 2018
- Quantity
- 163,694 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALLERGAN
Original FDA data
Every field from FDA enforcement report D-0545-2018, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 78755
- Address
- 1 Giralda Farms
- Code information
- Lot# 15W05A, Exp.FEB-2018; 16W02A, Exp. DEC 2018; 16W05A, Exp. JAN-2019; 16W13A, Exp. APR-2019; 16W15A, 16W16A, 16W17A, Exp. MAY 2019; 16W18A, Exp. JUN 2019; 16W20A, 16W22A, Exp. SEP 2019; 17W01A, 17W02A, Exp. DEC-2019; 17W04A, 17W05A, Exp. JAN 2020; 17W09A, Exp. MAR-2020; 17W11A, 17W13A, Exp. MAY 2020; 17W14A, 17W15A, Exp. JUN 2020
- Postal code
- 07940-1027
- Report date
- Mar 7, 2018
- Product type
- Drugs
- Recall number
- D-0545-2018
- Classification
- Class II
- Recalling firm
- ALLERGAN
- Product quantity
- 163,694 cartons
- Termination date
- Apr 8, 2020
- Reason for recall
- Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Product was distributed nationwide in the USA.
- Recall initiation date
- Dec 13, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 23, 2018