INFed — Class II drug recall D-0282-2019
Terminated recall by ALLERGAN, reported 2018-12-05, distributed nationwide. Failed Stability Specification: out of specification for iron content.
| Recall number | D-0282-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALLERGAN, Madison, NJ, United States |
| Recall initiated | 2018-11-08 |
| Classified | 2018-11-23 |
| Reported by FDA | 2018-12-05 |
| Terminated | 2020-04-06 |
| Distributed | Nationwide (US) |
| Reason classes | specification failure |
| NDC | 52544-0931-07 |
| Lot numbers | 16W06A, 16W07A, 16W08A, 16W09A, 16W10A, 16W11A, 16W14A, 16W21A, 16W23A, 17W10A, 17W12A, 17W16A, 17W18A, 17W22A |
| Expiration dates | 2019-02, 2019-03, 2019-04, 2019-09, 2019-11, 2020-04, 2020-05, 2020-06, 2020-08 |
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
Reason for recall
Failed Stability Specification: out of specification for iron content.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0282-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.