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Provident Nutraceutical div. of Ortho Molecular Products Inc Recall: Various branded dietary supplements may contain undeclared soy.

United States

TerminatedClass II

Company
Provident Nutraceutical div. of Ortho Molecular Products Inc
Product
Dietary supplements, 60 capsules, UPC 15033-61832, Product…
Recall date
July 16, 2020
Terminated
February 24, 2021
Source
FDA

Reason for recall

Various branded dietary supplements may contain undeclared soy.

  1. - Recall initiated
  2. - Reported by source
  3. - Recall terminated
Recalled products
Product description UPC Quantity Lot / code information
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. . 15033-61832 95 bottles Lot 83659F EXP 09/30/2021

Distribution

  • CA
  • FL
  • OH
  • TX
  • WA

Official source record

Agency
FDA
Dataset
FDA Food Enforcement (Recalls)
Recall number
F-1049-2020
Event ID
86086
Status
Terminated
Classification
Class II
Company
Provident Nutraceutical div. of Ortho Molecular Products Inc
Product description
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. .
Quantity
95 bottles
Reason
Various branded dietary supplements may contain undeclared soy.
Recall initiation date
July 16, 2020
Report date
August 12, 2020
Classification date
Not published in this source record
Termination date
February 24, 2021
Distribution pattern
CA, FL, OH, TX, WA
UPC, lot, and code information
UPC 15033-61832; Lot 83659F EXP 09/30/2021
Voluntary or mandated
Voluntary: Firm initiated
Initial notification method
Telephone
Source last updated
Not tracked separately from the Public Health Trace retrieval date below
Public Health Trace retrieval date

Responsible company: Provident Nutraceutical div. of Ortho Molecular Products Inc

Distribution map

A map highlighting the states named in the source's distribution description.

Shading reflects state-level totals only, as published by the source. It does not imply county-level or point-level precision.

Distribution map
State Distributed
California 1
Florida 1
Ohio 1
Texas 1
Washington 1

States shown are extracted from the source's free-text distribution description above; a narrative description (e.g. "distributed nationwide") may not list individual states to extract.

Where this information comes from

View FDA enforcement record -- the specific openFDA record this summary was built from.

No separate FDA public notice was found for this enforcement record. The information below comes from FDA's Recall Enterprise System through openFDA.

FDA Enforcement Reports -- FDA's general, official recall and enforcement information.

Technical source data

View raw source data -- the machine-readable record this page's information was built from.

Retrieved by Public Health Trace:

Frequently asked questions

What does a Class II mean?

A situation in which use of or exposure to a product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote.

Is this recall still active?

According to FDA, this recall's status is "Terminated." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.

What should I do if I have this product?

Follow the instructions published by the responsible agency (see the source links below) -- recall guidance (e.g. dispose of the product, return it for a refund, or check for a specific lot number) varies by recall and is set by that agency, not by Public Health Trace.

Where can I find more official information?

The source links below, published by FDA, are the authoritative record for this recall, including any updates issued after this summary was retrieved.

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