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Class II: temporary or reversible health riskTerminated

Provident Nutraceutical div. of Ortho Molecular Products Dietary supplements Recall

Dietary supplements, 60 capsules, UPC 15033-61832, Product # 832060, labeled under th…

Provident Nutraceutical div. of Ortho Molecular Products Inc · Stevens Point, WI

Risk level
Class II
Reported by FDA
Aug 12, 2020
Recall ID
F-1049-2020
Check your lot numberHow we source this data

Summary

Provident Nutraceutical div. of Ortho Molecular Products recalled Dietary supplements starting Jul 16, 2020. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report F-1049-2020 on Aug 12, 2020. Reason: Various branded dietary supplements may contain undeclared soy. Status: Terminated.

Why it was recalled

Various branded dietary supplements may contain undeclared soy.

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. .

Lot numbers, UPCs & expiration codes

Lot 83659F EXP 09/30/2021

Where it was sold

CA, FL, OH, TX, WA

What to do if you have this product

  • Compare the brand, size, and lot/UPC codes on your package with the codes above.
  • If it matches, don't eat it. Return it to the store for a refund or throw it away.
  • Wash surfaces and containers that touched the product.
  • If you feel sick after eating it, contact your doctor. In an emergency call 911.

Recall details

Recall number
F-1049-2020
Classification
Class II
Status
Terminated
Recall initiated
Jul 16, 2020
FDA report date
Aug 12, 2020
Quantity
95 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Provident Nutraceutical div. of Ortho Molecular Products Inc

Original FDA data

Every field from FDA enforcement report F-1049-2020, exactly as published.

Show all FDA fields
City
Stevens Point
State
WI
Status
Terminated
Country
United States
Event ID
86086
Address
3017 Business Park Dr
Code information
Lot 83659F EXP 09/30/2021
Postal code
54482-8835
Report date
Aug 12, 2020
Product type
Food
Recall number
F-1049-2020
Classification
Class II
Recalling firm
Provident Nutraceutical div. of Ortho Molecular Products Inc
Product quantity
95 bottles
Termination date
Feb 24, 2021
Reason for recall
Various branded dietary supplements may contain undeclared soy.
Voluntary / mandated
Voluntary: Firm initiated
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. .
Distribution pattern
CA, FL, OH, TX, WA
Recall initiation date
Jul 16, 2020
Initial firm notification
Telephone
Center classification date
Aug 4, 2020

How we source this data

Source: U.S. Food and Drug Administration enforcement report F-1049-2020, published Aug 12, 2020. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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