Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals…

Date

Aug. 19, 2020

Risk class

Class I (FDA's definition, 21 CFR 7.3(m): 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)

Status

Terminated

Filed by

Advanced Compounds International, Inc.

Product

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

Reason

Product contains undeclared milk allergen.

Distribution pattern

NJ, NE

Quantity

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

Codes and lots

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

Recall started

July 24, 2020

Recall number

F-1150-2020

What should I do? Food recall: what to do with it

Source: FDA · Food enforcement report, recall number F-1150-2020. The agency record governs; check it and the company before acting.