FindMyRecallSubscribe
Class II: temporary or reversible health riskTerminated

Gary Wood hCG Body Shaper Recall

hCG Body Shaper, Highly Purified Human Chorionic Gonadotrophin 5000 IU, Colloidal Silve…

Gary Wood · Saint Peters, MO

Risk level
Class II
Reported by FDA
May 3, 2017
Recall ID
D-0677-2017
Check your lot numberHow we source this data

Summary

Gary Wood recalled hCG Body Shaper starting Mar 28, 2017. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0677-2017 on May 3, 2017. Reason: Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug. Status: Terminated.

Why it 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

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

Lot numbers, UPCs & expiration codes

No code information printed on bottle

Where it was sold

Nationwide

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0677-2017
Classification
Class II
Status
Terminated
Recall initiated
Mar 28, 2017
FDA report date
May 3, 2017
Quantity
1305-1400 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Gary Wood

Original FDA data

Every field from FDA enforcement report D-0677-2017, exactly as published.

Show all FDA fields
City
Saint Peters
State
MO
Status
Terminated
Country
United States
Event ID
76680
Address
1810 Oak Tree St
Code information
No code information printed on bottle
Postal code
63376-6617
Report date
May 3, 2017
Product type
Drugs
Recall number
D-0677-2017
Classification
Class II
Recalling firm
Gary Wood
Product quantity
1305-1400 bottles
Termination date
May 8, 2019
Reason for recall
Marketed without an Approved NDA/ANDA; FDA analysis has found the product to be tainted with human chorionic gonadotropin, rendering it an unapproved drug
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide
Recall initiation date
Mar 28, 2017
Initial firm notification
Letter
Center classification date
Apr 21, 2017

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0677-2017, published May 3, 2017. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

How we source and update recall data · Report incorrect information

Other recent drug recalls