Recall record at a glance
| Official record | D-0677-2017 |
|---|---|
| Category | Drug Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Gary Wood |
| Report date | May 3, 2017 |
| Recall initiation date | Mar 28, 2017 |
| Quantity | 1305-1400 bottles |
| Location | Saint Peters, MO, United States |
Official product description
hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silver B12, Stabilizers/Excipients, Not For Medical Use, Must Be Refrigerated, Distributed by HCG Body Shaper, St. Peters, MO
Why the product was recalled
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Distribution information
Nationwide
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: Letter.
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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