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Home / Food recalls / 2016

Zochem Inc.

FDA recall F-1402-2016 · Class III · reported 2016-06-01 · Terminated

Product
Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .
Reason
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
Quantity
(Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed
Distribution
(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.
Firm location
N/A, Canada
Initiated
Voluntary: Firm initiated
First notice
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall started
2016-03-11
Terminated
2016-11-03
Code info
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

Source: U.S. Food and Drug Administration, openFDA Food Enforcement database (openFDA Food Enforcement, imported 2026-09). The FDA does not validate openFDA data for completeness or accuracy. This is a record of an enforcement action, not safety advice.