Cays LLC Recalls Addback Tablets Due to Undeclared Coating Ingredients
Cays LLC is recalling 2,095 bottles of Addback Tablets because the product contains undeclared coating ingredients and lists an ingredient not in the formulation.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a situation that may cause temporary or medically reversible health adverse effects. The hazard involves undeclared ingredients and labeling errors, which fits the criteria for moderate severity.
Plain-English summary
Cays LLC, a division of Prevent D Labs, is voluntarily recalling 2,095 bottles of Addback Tablets. The recall is due to the presence of undeclared coating ingredients, including HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, and FD & C Blue # 1. Additionally, the product label lists Silicon Dioxide, which is not part of the actual formulation.
The affected product is identified by Lot # 1810553 and an expiration date of 12/2020. The product is a dietary supplement containing 60 tablets per 190cc oblong WHDPE bottle with a net weight of 85gm. The UPC for the product is 0651536124526.
All product is currently in the firm's possession. Consumers who have purchased this product should stop using it and contact the firm for further instructions.
The recalled product
- Product
- Addback Tablet Dietary Supplement 60 tablets per 190cc Oblong WHDPE bottle Net Wet: 85gm (60 tablet wt) UPC- 0651536124526 Firm name Prevent D Labs Division of CAYS, LLC Southington, CT
- Manufacturer
- Cays LLC
- Category
- Food — Dietary Supplement
- Affected units
- 2,095
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)
- Code NS-1930F Lot # 1810553 Exp. Date 12/2020
Distribution
Distribution scope not specified by the agency.
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