Recall record at a glance
| Official record | F-1295-2019 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Cays LLC |
| Report date | Apr 24, 2019 |
| Recall initiation date | Mar 29, 2019 |
| Quantity | 2095 bottles |
| Location | Southington, CT, United States |
Official product description
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
Why the product was recalled
Undeclared coating ingredients: HPMC, Triacetin, Titanium Dioxide, FD & C Yellow # 5, FD & C Yellow # 6, FD & C Blue # 1. In addition, the label states Silicon Dioxide, which is not part of the formulation
Distribution information
All product is in the firm's possession.
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
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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