The Recall Desk
HighFDA (Food)·F-1150-2020·Announced 2020-08-19

Iron (III) Hydroxide Polysaccharides Complex Recalled for Undeclared Milk Allergen

Advanced Compounds International is recalling Iron (III) Hydroxide Polysaccharides Complex because the product contains an undeclared milk allergen.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves allergen mislabeling on a common allergen (milk), which corresponds to a High severity score per the rubric.

Plain-English summary

Advanced Compounds International, Inc. is recalling Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums. The product was manufactured by Chaitanya Biologicals Pvt. Ltd in Buldhana, India. The recall is being conducted because the product contains an undeclared milk allergen.

The recall involves 60 drums, totaling 1500Kg. The affected batches are PIC/B181008, PIC/B181007, and PIC/B171001. These batches were manufactured in October 2017 and February 2018, with expiration dates in September 2020 and January 2021.

The product was distributed in New Jersey and Nebraska. Consumers and businesses who have purchased this product should stop using it and contact Advanced Compounds International for instructions on how to return or dispose of the product safely.

The recalled product

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

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (9)

  • 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

Distribution

Distributed in 2 states: