Advanced Compounds International, Inc. Recall: Product contains undeclared milk allergen.
United States
TerminatedClass I
- Company
- Advanced Compounds International, Inc.
- Product
- Iron (III) Hydroxide Polysaccharides Complex in 25kg polyeth…
- Recall date
- July 24, 2020
- Terminated
- April 29, 2021
- Source
- FDA
Reason for recall
Product contains undeclared milk allergen.
- - Recall initiated
- - Reported by source
- - Recall terminated
| Product description | UPC | Quantity | Lot / code information |
|---|---|---|---|
| Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India | Not published in this source record | 60 drums (25Kg/drum); 1500Kg total | 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
- NJ
- NE
Official source record
- Agency
- FDA
- Dataset
- FDA Food Enforcement (Recalls)
- Recall number
- F-1150-2020
- Event ID
- 86111
- Status
- Terminated
- Classification
- Class I
- Company
- Advanced Compounds International, Inc.
- Product description
- Iron (III) Hydroxide Polysaccharides Complex in 25kg polyethylene drums manufactured by Chaitanya Biologicals Pvt. Ltd, Buldhana, India
- Quantity
- 60 drums (25Kg/drum); 1500Kg total
- Reason
- Product contains undeclared milk allergen.
- Recall initiation date
- July 24, 2020
- Report date
- August 19, 2020
- Classification date
- Not published in this source record
- Termination date
- April 29, 2021
- Distribution pattern
- NJ, NE
- UPC, lot, and code information
- 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
- Voluntary or mandated
- Voluntary: Firm initiated
- Initial notification method
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Source last updated
- Not tracked separately from the Public Health Trace retrieval date below
- Public Health Trace retrieval date
Responsible company: Advanced Compounds International, Inc.
A map highlighting the states named in the source's distribution description.
Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.
| State | Distributed |
|---|---|
| New Jersey | 1 |
| Nebraska | 1 |
States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.
Where this information comes from
View FDA enforcement record -- the specific openFDA record this summary was built from.
No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Technical source data
View raw source data -- the machine-readable record this page's information was built from.
Retrieved by Public Health Trace:
Frequently asked questions
What does a Class I mean?
A situation in which there is a reasonable probability that use of or exposure to a product will cause serious adverse health consequences or death.
Is this recall still active?
According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this product?
Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.
Where can I find more official information?
The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.
This summary is based on the official source record referenced above. Public Health Trace does not state that any company or product is unsafe beyond what the official source has published. Read the full medical disclaimer.
