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

Zochem INC. recalled Zinc Oxide Powder (API) used in the manufacturing of dietary supplements in a Class III action, the FDA tier used when a product is unlikely to cause adverse health effects, typically for labeling or minor regulatory issues on Mar 11, 2016.

The FDA-published reason for this recall is: "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"

The product reached multiple states, recorded by the FDA as "(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." A multi-state footprint means the same lot can surface in households far from the producer. The recalling firm is based in Brampton, N/A. The recall covers (Lot # 700785 & 700804) of 19200 lbs each (total 38400 lbs) , lot (LOT#700792) of 450 kg was made and distributed of product. The FDA has Terminated this recall (first reported Jun 1, 2016), its final lifecycle state, indicating the agency considers the corrective action resolved. The historical record remains useful for tracking a brand's recall pattern over time.