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Recall Observatory FDA recall evidence

Food product

Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .

F-1402-2016

March 11, 2016

Class III

Product summary

Firm
Zochem Inc.
Event
Event 73599
Status
Terminated
Classification
Class III
Quantity
(Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed
Official record key
food-enforcement:F-1402-2016

Official wording

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

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

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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