Class IIIFDA11 Mar 2016F-1402-2016

Zochem Inc. recalls Zinc Oxide Powder (API) used in the manufacturing of dietary supplements . (Class III)

Class III — Eating this product is not likely to cause health problems, but it violates FDA labelling or manufacturing rules.

Product

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

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

Affected products (1)

Recall #	Product	Lot / code	Status
F-1402-2016	Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .	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	Terminated

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