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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

ALLERGAN: INFed (Iron Dextran Injection) Recalled for Incorrect Iron Content

Agency Publication Date: November 23, 2018
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Summary

Allergan is recalling 111,132 cartons (each containing 10 vials) of INFed (iron dextran injection USP) 100 mg elemental iron/2 mL (50 mg/mL). The recall was issued because the medication failed stability testing, showing iron content that was outside of the required specifications. Using a medication with incorrect iron levels may result in patients receiving a dosage that is different than what was prescribed by their doctor.

Risk

The medication was found to have iron content outside of its approved specifications during stability testing. This instability could lead to ineffective treatment of iron deficiency or potential adverse reactions if the iron concentration does not meet safety standards.

What You Should Do

  1. Check your INFed (Iron Dextran Injection USP) 2 mL Sterile Single Dose Vials for NDC 52544-931-07 and the following lot numbers: 16W06A, 16W07A, 16W08A (Exp 02/2019); 16W09A, 16W10A (Exp 03/2019); 16W11A, 16W14A (Exp 04/2019); 16W21A (Exp 09/2019); 16W23A (Exp 11/2019); 17W10A (Exp 04/2020); 17W12A (Exp 05/2020); 17W16A, 17W18A (Exp 06/2020); or 17W22A (Exp 08/2020).
  2. If you have an affected lot, contact your healthcare provider or pharmacist immediately for guidance on using the product or obtaining a replacement.
  3. Return any unused vials or cartons to the pharmacy where they were purchased for a refund.
  4. Contact Allergan directly at 1-888-723-3332 for further instructions regarding this voluntary recall.
  5. For additional questions or to report a side effect, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

💰Full Refund

Contact healthcare provider and return to pharmacy

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: INFed (Iron Dextran Injection USP) 100 mg elemental iron/2 mL (50 mg/mL)
Model:
NDC 52544-931-07
Recall #: D-0282-2019
Lot Numbers:
16W06A (Exp 02/2019)
16W07A (Exp 02/2019)
16W08A (Exp 02/2019)
16W09A (Exp 03/2019)
16W10A (Exp 03/2019)
16W11A (Exp 04/2019)
16W14A (Exp 04/2019)
16W21A (Exp 09/2019)
16W23A (Exp 11/2019)
17W10A (Exp 04/2020)
17W12A (Exp 05/2020)
17W16A (Exp 06/2020)
17W18A (Exp 06/2020)
17W22A (Exp 08/2020)
Date Ranges: 02/2019, 03/2019, 04/2019, 09/2019, 11/2019, 04/2020, 05/2020, 06/2020, 08/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 81535
Status: Resolved
Manufacturer: ALLERGAN
Sold By: Pharmacies
Manufactured In: Italy, United States
Units Affected: 111,132 cartons/10 vials per carton
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.