Recall record at a glance
| Official record | F-1049-2020 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Provident Nutraceutical div. of Ortho Molecular Products Inc. |
| Report date | Aug 12, 2020 |
| Recall initiation date | Jul 16, 2020 |
| Quantity | 95 bottles |
| Location | Stevens Point, WI, United States |
Official 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. .
Why the product was recalled
Various branded dietary supplements may contain undeclared soy.
Distribution information
CA, FL, OH, TX, WA
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Telephone.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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