Drug product
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
D-0282-2019
Product summary
- Firm
- ALLERGAN
- Event
- Event 81535
- Status
- Terminated
- Classification
- Class II
- Quantity
- 111,132 cartons/10 vials per carton
- Official record key
drug-enforcement:D-0282-2019
Official wording
Reason: Failed Stability Specification: out of specification for iron content.
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
Distribution pattern: Product was distributed throughout the United States.
Derived failure modes
-
Potency or specification failure
out of specification