Zochem Recalls Zinc Oxide Powder Contaminated with Iron
Zochem Inc. is recalling zinc oxide powder lots contaminated with iron. The product is used in manufacturing dietary supplements and drugs.
The agency’s classification
FDA (Food): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates a remote possibility of adverse health consequences. The hazard is identified as iron contamination, which is a low-risk contamination issue without reported illnesses.
Plain-English summary
Zochem Inc. is recalling specific lots of Zinc Oxide Powder (API) used in the manufacturing of dietary supplements. The recall was initiated after a customer complaint reported black specs of contamination in Lot #700792. An investigation by Zochem Inc. determined that the contaminant was iron.
The recall includes Lot #700792 (450 kg), which was distributed to M K Impex in Canada. The company also identified that the issue is potentially present in two other lots: Lot #700785 and Lot #700804 (19,200 lbs each), which were distributed to Brand Nu Laboratories in the United States. In the US, the potentially contaminated product was used in the manufacturing of drugs. In Canada, 200 kg of the 450 kg lot was distributed in Saudi Arabia, while the remaining 200 kg is on hold with the distributor.
The FDA has classified this as a Class III recall. Consumers and manufacturers should stop using the affected lots and contact the recalling firm for further instructions.
The recalled product
- Product
- Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
- Manufacturer
- Zochem Inc.
- 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 (4)
- Lot # 700785
- expiration date: 07/19/2017 (manufactured 07/20/15) - US Lot #700804
- expiration date: 07/28/2017 (manufactured 07/29/15) - US Lot# 700792
- expiration date: 07/22/2017 (manufactured 07/23/15) - Canada
Distribution
Distribution scope not specified by the agency.
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