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

Recall date

March 11, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

F-1402-2016

FDA classification

Class III

Brand / firm

Zochem Inc.

Sold / distributed

(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…

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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