Safety Alerts & Recalls

What does this mean?

This seizure notice only applies to Pramoxine-HC Otic Drops, Hydrocortisone Acetate Suppositories 25 mg, Urea Cream 39%, Urea Cream 40%, or Urea Lotion 40% products manufactured for Ascend Laboratories of Montvale, NJ, and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, OH.

If you are using Pramoxine-HC Otic Drops, Hydrocortisone Acetate Suppositories 25 mg, Urea Cream 39%, Urea Cream 40%, or Urea Lotion 40%, please check your prescription to determine the company involved in manufacturing your medicine. Please consult your healthcare provider or pharmacist if you think your medicine was manufactured for Ascend Laboratories or if you are unsure what company it came from. Your healthcare provider can advise you about whether to continue the use of this particular medicine.

Contact your healthcare provider if you have any questions about this safety alert or your medicine.

Patients and healthcare providers are encouraged to report side effects related to the use of medicines to the FDA's MedWatch program. You can reach MedWatch by:

--- Telephone: 1-800-332-1088

--- Fax: 1-800-332-0178

--- Mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787

--- Website: www.fda.gov/Safety/MedWatch

FDA Requests Seizure of Unapproved Drugs Marketed by Ascend Laboratories of Montvale, NJ

US Marshals recently seized more than $11 million worth of unapproved products marketed by Ascend Laboratories of Montvale, NJ, and distributed by Masters Pharmaceuticals, Inc. of Cincinnati, OH.

The seized products included: - Pramoxine-HC Otic Drops, intended to treat infections of the external ear and control itching

- Hydrocortisone Acetate Suppositories 25 milligrams (mg), intended to treat inflamed hemorrhoids, ulcerative colitis, and other inflammatory condition

- Urea Cream 39%, Urea Cream 40%, and Urea Lotion 40%, intended to treat skin-thickening conditions such as dermatitis and eczema.

The US Food and Drug Administration (FDA) requested the seizure because these products were being marketed without having been proven safe or effective for their intended uses. These unapproved products may be of uncertain quality and do not have FDA-approved labeling. As a result, these drugs may pose risks to patients.

For more information, please visit: more information here

Source: FDA
Publication Date: 2014-05-21
Last Updated: 2014-05-21

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