INFeD — Class II drug recall D-0545-2018
Terminated recall by ALLERGAN, reported 2018-03-07, distributed nationwide. Failed Stability Specifications: Product stability testing results did not meet specifications for iron conten
| Recall number | D-0545-2018 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALLERGAN, Madison, NJ, United States |
| Recall initiated | 2017-12-13 |
| Classified | 2018-02-23 |
| Reported by FDA | 2018-03-07 |
| Terminated | 2020-04-08 |
| Distributed | Nationwide (US) |
| Quantity | 163,694 cartons |
| Reason classes | specification failure |
| NDC | 52544-0931-02, 52544-0931-07 |
| Lot numbers | 15W05A, 16W02A, 16W05A, 16W13A, 16W15A, 16W16A, 16W17A, 16W18A, 16W20A, 16W22A, 17W01A, 17W02A, 17W04A, 17W05A, 17W09A, 17W11A, 17W13A, 17W14A, 17W15A, APR-2019, DEC-2019, FEB-2018, JAN-2019, MAR-2020 |
| Expiration dates | 2018-12-20, 2019-05-20, 2019-06-20, 2019-09-20, 2020-01-20, 2020-05-20, 2020-06-20 |
Product
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.
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-0545-2018. 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.