Food recall

Provident Nutraceutical div. of Ortho Molecular Products Inc recall: Dietary supplements

Provident Nutraceutical div. of Ortho Molecular Products Inc, of Stevens Point, WI, recalled Dietary supplements. The FDA's reason: “Various branded dietary supplements may contain undeclared soy.” The FDA classified it Class II: it could cause temporary or minor harm. The company began the recall voluntarily on July 16, 2020, and the FDA first listed it in its Enforcement Report of August 12, 2020. The FDA has closed the recall: it found the company did all it reasonably could to remove or correct the product.

How serious

Class II

It could cause temporary or minor harm

Why

Allergen not on the label

Status

Terminated

Closed February 24, 2021

The recall

Company
Provident Nutraceutical div. of Ortho Molecular Products Inc (Stevens Point, WI)
Reason, in FDA's words
“Various branded dietary supplements may contain undeclared soy.”
Where it was sold
CA, FL, OH, TX, WA
Recall began
, by the company
FDA classified it
First in an FDA Enforcement Report
FDA event number
86086

The product recalled

As the FDA describes them, with the codes that tell whether a package is part of the recall.

  • F-1049-2020 Class II

    Dietary supplements, 60 capsules, UPC 15033-61832, Product # 832060, labeled under the following brands and product names, packaged in white plastic bottle with black plastic lid: 1. Aspire Rejuvenation Nutraceuticals, Tranquility PM, Mfg for: Aspire Rejuvenation Nutraceuticals, 74550 Dr Phillips Blvd Ste 205, Orlando, FL 32819. 2. Living Well Clinical Nutrition Center, SleepForce, Manufactured for: living Well Clinical Nutrition, 815 E. Main St Ste A, League City, TX 77573. 3. Swiss Rx Superior Human Performance, Nighttime, Manufactured for Swiss Rx, 1668 Valtec LN STE H, Boulder, CO 80301. 4. energy health, Neuro Calm PM, Mfg for: Energy Health, 709 W. Leuda St., Fort Worth, TX 76104. 5. Nutra Molecular, Nutra Calm PM, Manufactured for: Nutra Molecular, 1543 S Bowen Rd, Pantego, TX 76013. 6. Good Medicine NeuroSleep, Manufactured for: Good Medicine, 5235 Morning Sun Rd, Oxford, OH 45056. 7. WiseMeds Tranquil PM + GABA, Neurotransmitter Support for a Healthy Sleep Cycle. Distributed by: WiseMeds, 534 S. Chickasaw Trail, Orlando, FL 32825. .

    Codes: Lot 83659F EXP 09/30/2021

    Quantity: 95 bottles

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Source and notes

U.S. Food and Drug Administration, Enforcement Reports (openFDA food recall data) (Public domain (U.S. government work); source U.S. Food and Drug Administration, openFDA), data as of August 12, 2020.

Each week the FDA lists the recalls it has classified in its Enforcement Report, often weeks after the company announced the recall, so a month with five weekly reports tends to count more. Each recall counts once, however many products it covers, in the month FDA first listed it. Class I means the food could cause serious harm or death, Class II temporary or minor harm, and Class III is unlikely to harm anyone. Meat, poultry and most egg products are recalled by the U.S. Department of Agriculture, not the FDA, and aren't included. For what to do with a recalled product, see the FDA's recalls page.