Zinc Oxide Powder (Api) Used in the Manufacturing of Dietary Supplements
What you need to know
Class III
What happened
ZoChem Inc. received a complaint from a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an…
Health risk
The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. A safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
Action required
Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure.
(2) lots (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) were made and distributed to Brand Nu Laboratories (distributor) at the following address: 377 Research Parkway, Meriden, CT 06450. One (1) lot (LOT#700792) of 450 kg was made and distributed to M K Impex, Canada at the following address: C/O Rexway Transport, Ltd. 2869 Slough Street, Mississauga, ON. L4T 1G4. Additional information: In the US, all of the potentially contaminated product was used in the manufacturing of drugs. In Canada, 200 kg of 450 kg of the potentially contaminated product has been distributed in Saudi Arabia while the remaining 200 kg is in the distributors control and has been put on hold.
United States, Canada
Quantity affected
(Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs), lot (LOT#700792) of 450 kg was made and distributed
Recall initiation
FDA report date: June 1, 2016
FDA recall number
F-1402-2016
Beyond the headline
The recall, in context
Zochem INC. initiated this supplements recall on March 11, 2016. The FDA enforcement report states: ZoChem Inc. received a complaint from a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an investigation by ZoChem Inc. was launched. The retained sample representing this lot was analyzed and the contaminant was determined to be iron. The issue is potentially present in two other lots (#700785 & 700804) produced. The FDA report lists distribution as: (2) lots (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) were made and distributed to Brand Nu Laboratories (distributor) at the following address: 377 Research Parkway, Meriden, CT 06450. One (1) lot (LOT#700792) of 450 kg was made and distributed to M K Impex, Canada at the following address: C/O Rexway Transport, Ltd. 2869 Slough Street, Mississauga, ON. L4T 1G4. Additional information: In the US, all of the potentially contaminated product was used in the manufacturing of drugs. In Canada, 200 kg of 450 kg of the potentially contaminated product has been distributed in Saudi Arabia while the remaining 200 kg is in the distributors control and has been put on hold.
The FDA enforcement report describes the reason as: ZoChem Inc. received a complaint from a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an investigation by ZoChem Inc. was launched. The retained sample representing this lot was analyzed and the contaminant was determined to be iron. The issue is potentially present in two other lots (#700785 & 700804) produced
Zinc Oxide Powder (Api) Used in the Manufacturing of Dietary Supplements was made or distributed by Zochem INC. in Brampton, Canada. This page reflects FDA report F-1402-2016, dated June 1, 2016.
Why this is a Class III recall
Class III means the product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations. In this recall, a safety issue that does not fit the standard pathogen, allergen, chemical or quality categories.
FDA definition
The product is unlikely to cause adverse health consequences. These recalls are often related to labeling or quality violations.
What to do now
1
Stop using it
Do not eat, drink or take the affected product.
2
Check the codes
Compare the lot and date codes against the table above.
3
Return or discard
Contact the retailer or recalling firm about a refund, and dispose of the product safely.
Consumer safety guide
Product safety recall
Symptoms to watch for
The official enforcement report describes the specific risk. Follow the recall notice, check the product codes and do not use a product that may be affected.
Higher-risk groups
Children, pregnant people, older adults and people with weakened immune systems should take extra care when a product's safety is uncertain.
What to do now
1Stop using or eating the product and keep it away from children and pets.
2Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return.
3Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Read the official source record for the specific hazard and instructions.
This is general consumer safety information, not medical advice or a diagnosis. Follow the official recall notice and contact a healthcare professional if you have concerns about exposure or symptoms.
Frequently asked
Questions about this recall
4 answers
What is the Zinc Oxide Powder (Api) Used in the Manufacturing of Dietary Supplements recall?
Zochem INC. recalled Zinc Oxide Powder (Api) Used in the Manufacturing of Dietary Supplements in an FDA Class III enforcement action reported as F-1402-2016. ZoChem Inc. received a complaint from a customer who noticed black specs of contamination in one specific lot (#700792) of product (zinc oxide) that they received, an…
What should I do if I bought this product?
Stop taking the supplement. Check the lot and UPC codes below, then return it to the retailer or contact the manufacturer about a refund. Seek medical advice if you have concerns about exposure. Stop using or eating the product and keep it away from children and pets. Check the UPC and lot/date codes on this page and follow the official recall notice for disposal or return. Seek medical advice if anyone develops severe or worrying symptoms after exposure.
Is the Zochem INC. recall still active?
The FDA lists this recall as recall closed. It remains relevant if you still have the affected product or need to identify a historical recall.
Where can I verify this recall?
This page is normalized from the openFDA enforcement record F-1402-2016. You can verify it directly using the official source link on this page. VerifyRecall updates its index from public FDA enforcement data and does not replace advice from the FDA, the recalling firm or a healthcare professional.
Verify before you act.
VerifyRecall is independent and not affiliated with the FDA. Always confirm the latest status on the official source record.