Iron (III) Hydroxide Polysaccharides Complex in recall
Recalled by Advanced Compounds International, Inc. · Nanuet, NY, United States
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Product contains undeclared milk allergen.
Undeclared allergen: Milk
For someone with a food allergy the label is the only protection. An undeclared allergen can trigger a severe reaction even in a trace amount, which is why most of these recalls are Class I. All undeclared allergens recalls.
What was recalled
Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India
Quantity: 60 drums (25Kg/drum); 1500Kg total
Lot codes, dates and UPCs
A recall covers only these codes. Compare them with the lot number, best-by date or UPC printed on your package.
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
Where it was sold
Nebraska New Jersey
FDA's distribution note: NJ, NE
Do not eat it. Class I means FDA judged there is a reasonable probability of serious illness or death. If the brand, size and lot or date code on your package match, throw the product away or return it to the store for a refund, and clean any surface or container it touched. If anyone has eaten it and feels unwell, contact a doctor and mention the recall. The risk from an undeclared allergen is to people allergic to milk; for anyone else the product is generally not a safety concern. FDA lists this recall as terminated: the company has finished removing the product, so it should no longer be on shelves - but it can still be in a freezer or pantry.
- Recalling firm
- Advanced Compounds International, Inc.
- Initiated by
- Voluntary: Firm initiated
- Recall initiated
- Jul 24, 2020
- In FDA report of
- Aug 19, 2020
- Terminated
- Apr 29, 2021
- FDA recall number
- F-1150-2020 · event 86111
- Official record
- FDA enforcement report search