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Class III: unlikely to cause harmTerminated

Genesis Pharmaceutical Glytone Acne Recall

Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6

Genesis Pharmaceutical, Inc. · Henderson, NV

Risk level
Class III
Reported by FDA
May 7, 2014
Recall ID
D-1285-2014
Check your lot numberHow we source this data

Summary

Genesis Pharmaceutical recalled Glytone Acne starting Apr 1, 2014. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-1285-2014 on May 7, 2014. Reason: Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser. Status: Terminated.

Why it was recalled

Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.

Product description

Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2

Lot numbers, UPCs & expiration codes

Lot 54, Exp: 1/14/2016

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-1285-2014
Classification
Class III
Status
Terminated
Recall initiated
Apr 1, 2014
FDA report date
May 7, 2014
Quantity
461 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Genesis Pharmaceutical, Inc.

Original FDA data

Every field from FDA enforcement report D-1285-2014, exactly as published.

Show all FDA fields
City
Henderson
State
NV
Status
Terminated
Country
United States
Event ID
68098
Address
1710 Whitney Mesa Dr
Code information
Lot 54, Exp: 1/14/2016
Postal code
89014-2055
Report date
May 7, 2014
Product type
Drugs
Recall number
D-1285-2014
Classification
Class III
Recalling firm
Genesis Pharmaceutical, Inc.
Product quantity
461 Bottles
Termination date
Oct 15, 2014
Reason for recall
Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Glytone Acne, acne treatment facial cleanser, 2% Salicylic Acid, 200 mL/6.7 FL Oz Bottle, Distributed by Genesis Pharmaceuticals, Inc. a subsidiary of Pierre Fabre, Parsippany, NJ 07054, UPC 3 04760-00413-2
Distribution pattern
Nationwide
Recall initiation date
Apr 1, 2014
Initial firm notification
Letter
Center classification date
Apr 29, 2014

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1285-2014, published May 7, 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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