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.
The agency’s classification
FDA (Food): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Product contains undeclared milk allergen."
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
- Manufacturer
- Advanced Compounds International, Inc.
- Category
- Food — Food Ingredient
- Hazard
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
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