Health & Beyond Tranquility Supplement Recalled for Unapproved Prescription Drugs
Health & Beyond is recalling Tranquility dietary supplements because they contain unapproved prescription drugs, Doxepin and Chlorpromazine.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of undeclared prescription drugs (antidepressant and antipsychotic) in a dietary supplement poses a significant risk of serious adverse health consequences, meeting the criteria for a Severe rating.
Plain-English summary
Health & Beyond is recalling 46 bottles of Dr. Larry's Tranquility Dietary Supplement, 30 capsules. The product was distributed to consumers through the firm's website in Florida, Hawaii, California, Illinois, New York, Washington, and Pennsylvania. All lots with an expiration date of 09/2015 are affected.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Testing revealed that the dietary supplement contains Doxepin, an antidepressant, and Chlorpromazine, an antipsychotic. These are prescription medications that were not declared on the product label.
Consumers who purchased this product should stop using it immediately. They should contact Health & Beyond for further instructions on how to return the product or obtain a refund.
The recalled product
- Product
- HEALTH & BEYOND DR. LARRY'S Tranquility DIETARY SUPPLEMENT 30 Capsules Manufactured for: Health & Beyond 7050 W Palmetto Pk Rd Boca Raton, FL 33433.
- Manufacturer
- Health & Beyond
- Category
- Drug — Dietary Supplement
- Affected units
- 46
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots. Expiration date 09/2015.
Distribution
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