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Class II: temporary or reversible health riskOngoing

Invisiblu International LGD-Xtreme Recall

LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Cont…

Invisiblu International LLC · Fort Lauderdale, FL

Risk level
Class II
Reported by FDA
Jun 8, 2016
Recall ID
D-0910-2016
Check your lot numberHow we source this data

Summary

Invisiblu International recalled LGD-Xtreme starting Mar 31, 2016. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0910-2016 on Jun 8, 2016. Reason: Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033. Status: Ongoing.

Why it was recalled

Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033

Product description

LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL

Lot numbers, UPCs & expiration codes

Lot # 21511166, Exp 11/18

Where it was sold

Nationwide and Brazil.

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-0910-2016
Classification
Class II
Status
Ongoing
Recall initiated
Mar 31, 2016
FDA report date
Jun 8, 2016
Quantity
3,319 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Invisiblu International LLC

Original FDA data

Every field from FDA enforcement report D-0910-2016, exactly as published.

Show all FDA fields
City
Fort Lauderdale
State
FL
Status
Ongoing
Country
United States
Event ID
73698
Address
620 SE 13th St
Code information
Lot # 21511166, Exp 11/18
Postal code
33316-2023
Report date
Jun 8, 2016
Product type
Drugs
Recall number
D-0910-2016
Classification
Class II
Recalling firm
Invisiblu International LLC
Product quantity
3,319 bottles
Reason for recall
Marketed Without An Approved NDA/ANDA: Contains an unapproved drug, ligandrol LGD-4033
Voluntary / mandated
Voluntary: Firm initiated
Product description
LGD-Xtreme (ligandrol LGD-4033),capsules, 3 mg, 90-count bottle, Manufactured for Continuum Labs, Fort Lauderdale, FL
Distribution pattern
Nationwide and Brazil.
Recall initiation date
Mar 31, 2016
Initial firm notification
Press Release
Center classification date
May 27, 2016

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0910-2016, published Jun 8, 2016. 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.

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