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Class II: temporary or reversible health riskTerminated

Chaotic Labz MAYHEM capsules Recall

MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaoti…

Chaotic Labz · Atkins, AR

Risk level
Class II
Reported by FDA
Dec 31, 2014
Recall ID
D-0314-2015
Check your lot numberHow we source this data

Summary

Chaotic Labz recalled MAYHEM capsules starting Nov 14, 2014. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0314-2015 on Dec 31, 2014. Reason: Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug. Status: Terminated.

Why it was recalled

Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.

Product description

MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.

Lot numbers, UPCs & expiration codes

Lot#: CLM061114, Exp 06/16

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-0314-2015
Classification
Class II
Status
Terminated
Recall initiated
Nov 14, 2014
FDA report date
Dec 31, 2014
Quantity
990 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Chaotic Labz

Original FDA data

Every field from FDA enforcement report D-0314-2015, exactly as published.

Show all FDA fields
City
Atkins
State
AR
Status
Terminated
Country
United States
Event ID
69779
Address
220 Hankins Dr
Code information
Lot#: CLM061114, Exp 06/16
Postal code
72823-2834
Report date
Dec 31, 2014
Product type
Drugs
Recall number
D-0314-2015
Classification
Class II
Recalling firm
Chaotic Labz
Product quantity
990 bottles
Termination date
Jan 13, 2017
Reason for recall
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared dexamethasone and cyproheptadine which are FDA approved drugs making this product an unapproved drug.
Voluntary / mandated
Voluntary: Firm initiated
Product description
MAYHEM capsules, Proprietary Blend 525 mg, Dietary Supplement, 60-count bottles, Chaotic-Labz, UPC 6 28586 67805 7.
Distribution pattern
Nationwide.
Recall initiation date
Nov 14, 2014
Initial firm notification
Press Release
Center classification date
Dec 22, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0314-2015, published Dec 31, 2014. 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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