Food recall

Advanced Compounds International, Inc. recall: Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt

Advanced Compounds International, Inc., of Nanuet, NY, recalled Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. The FDA's reason: “Product contains undeclared milk allergen.” The FDA classified it Class I: it could cause serious harm or death. The company began the recall voluntarily on July 24, 2020, and the FDA first listed it in its Enforcement Report of August 19, 2020. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class I

It could cause serious harm or death

Why

Allergen not on the label

Status

Terminated

Closed April 29, 2021

The recall

Company
Advanced Compounds International, Inc. (Nanuet, NY)
Reason, in FDA's words
“Product contains undeclared milk allergen.”
Where it was sold
NJ, NE
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
86111

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1150-2020 Class I

    Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India

    Codes: BATCH NO. PIC/B181008; MFG DT.L FEB 2018; EXP. DT.: JAN-2021; BATCH NO.: PIC/B181007, MFG. DT.: FEB 2018, EXP.DT.: JAN 2021; BATCH NO.: PIC/B171001, MFG. DT. OCT 2017, EXP. DT. SEP 2020

    Quantity: 60 drums (25Kg/drum); 1500Kg total

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 19, 2020.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.