Why it was recalled
Failed Stability Specification: out of specification for iron content.
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
Lot numbers, UPCs & expiration codes
Lot Numbers: 16W06A, 16W07A, 16W08A, exp. date 02/2019; 16W09A, 16W10A, exp. date 03/2019; 16W11A, 16W14A, exp. date 04/2019; 16W21A, exp. date 09/2019; 16W23A, exp. date 11/2019; 17W10A, exp. date 04/2020; 17W12A, exp. date 05/2020; 17W16A, 17W18A, exp. date 06/2020; 17W22A, exp. date 08/2020
Where it was sold
Product was distributed throughout the United States.
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-0282-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 8, 2018
- FDA report date
- Dec 5, 2018
- Quantity
- 111,132 cartons/10 vials per carton
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ALLERGAN
Original FDA data
Every field from FDA enforcement report D-0282-2019, exactly as published.
Show all FDA fields
- City
- Madison
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81535
- Address
- 1 Giralda Farms
- Code information
- Lot Numbers: 16W06A, 16W07A, 16W08A, exp. date 02/2019; 16W09A, 16W10A, exp. date 03/2019; 16W11A, 16W14A, exp. date 04/2019; 16W21A, exp. date 09/2019; 16W23A, exp. date 11/2019; 17W10A, exp. date 04/2020; 17W12A, exp. date 05/2020; 17W16A, 17W18A, exp. date 06/2020; 17W22A, exp. date 08/2020
- Postal code
- 07940-1027
- Report date
- Dec 5, 2018
- Product type
- Drugs
- Recall number
- D-0282-2019
- Classification
- Class II
- Recalling firm
- ALLERGAN
- Product quantity
- 111,132 cartons/10 vials per carton
- Termination date
- Apr 6, 2020
- Reason for recall
- Failed Stability Specification: out of specification 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 2 mL Sterile Single Dose Vial, Mfd by Patheon Italia S.p.A. Ferentino, Italy NDC 52544-931-07
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Nov 8, 2018
- Initial firm notification
- Letter
- Center classification date
- Nov 23, 2018