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Medium RiskFDAfda-F-1402-2016CONTAMINATION

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

Category
Units Affected
700,785
Recall Date
March 11, 2016
Issuing Agency
Hazard
Contamination

FDA Recall Notice

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1402-2016.

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

Corrective Action (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1402-2016.

Recall terminated by FDA.

✅ What you should do

  1. Stop using the product if you own it.
  2. Check the model number, lot code, or sell-by date against the recall notice above.
  3. Contact Zochem Inc. or the retailer where you bought it for a refund, replacement, or repair.
  4. For the most current official instructions, visit the FDA recall page.
  5. If you've been hurt by this product, report the incident to FDA.

Consumer Contact (per FDA)

Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-F-1402-2016.

Zochem Inc.

FDA

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Zochem Inc. Recall FAQ

Zochem Inc. is the subject of a supplements safety report: Zinc Oxide Powder (API) used in the manufacturing of dietary supplements .. The notice was published on March 11, 2016 by the U.S. Food and Drug Administration (FDA). Approximately 700,785 units are potentially affected.