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FDA recall record

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

Recall F-1402-2016Class IIITerminatedMarch 11, 2016

FDA classification. FDA Class I, II, and III are not the same as USDA FSIS classifications and are not a cross-agency safety score.

FDA listed a termination date of November 3, 2016. openFDA does not treat this as a live recall-status tracker.

Product described in an FDA recall

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

Products involved

Product descriptions are copied from the FDA recall record. They are not a current catalog and are not automatically matched to WhoMadeMyFood product pages.

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

Code information listed by FDA

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 and firm information

Recalling firm listed by FDA: Zochem Inc.

Firm location listed by FDA: Brampton, N/A, Canada

Distribution reported by FDA: (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.

Product quantity listed by FDA: (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed

Source

Source: U.S. Food and Drug Administration (FDA), openFDA food enforcement reports.

Official FDA openFDA food enforcement record

Identifying an FDA recall record does not imply FDA endorsement of WhoMadeMyFood. Methodology.