Why it was recalled
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
Product description
Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
Lot numbers, UPCs & expiration codes
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
Where it was sold
(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.
What to do if you have this product
- Compare the brand, size, and lot/UPC codes on your package with the codes above.
- If it matches, don't eat it. Return it to the store for a refund or throw it away.
- Wash surfaces and containers that touched the product.
- If you feel sick after eating it, contact your doctor. In an emergency call 911.
Recall details
- Recall number
- F-1402-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Mar 11, 2016
- FDA report date
- Jun 1, 2016
- Quantity
- (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Zochem Inc.
Original FDA data
Every field from FDA enforcement report F-1402-2016, exactly as published.
Show all FDA fields
- City
- Brampton
- Status
- Terminated
- Country
- Canada
- Event ID
- 73599
- Address
- 1 Tilbury Crt
- Code information
- 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
- Report date
- Jun 1, 2016
- Product type
- Food
- Recall number
- F-1402-2016
- Classification
- Class III
- Recalling firm
- Zochem Inc.
- Product quantity
- (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed
- Termination date
- Nov 3, 2016
- Reason for recall
- 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
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
- Distribution pattern
- (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.
- Recall initiation date
- Mar 11, 2016
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- May 26, 2016