Recall -- Firm Press Release
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Pharmacy Creations Issues Voluntary Recall of Four Product Lots With Limited Distribution in Florida, New Jersey, New York, and Puerto Rico Due to Potential Non-Sterility
FOR IMMEDIATE RELEASE - September 4, 2014 - Randolph, NJ – Pharmacy Creations has voluntarily recalled four product lots (see below) following testing results conducted by Front Range, Inc., its former independent testing laboratory, that indicated that the product lots may have the potential of not being sterile. Pharmacy Creations no longer uses Front Range, Inc. for testing of any kind for any of its formulations.
Although we cannot be certain that the product subject to the recall is contaminated, to the extent it was, there are serious health implications for the use of contaminated product in all patients which could include development of a life-threatening infection. To date there have been NO reported adverse events associated with the use of the product.
The prescription preparations listed below were distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014 and June 18, 2014 and were mailed directly to patients and physicians.
|Product Name||Strength||Package Size||Lot Number||Expiry|
|Ascorbic Acid||500 mg/mL||50 mL vial||05082014@7||11/4/2014|
|Glutathione||100 mg/mL||30 mL vial||05122014@4||9/9/2014|
|Magnesium Chloride||200 mg/mL||50 mL vial||05202014@7||11/19/2014|
|Tropi/Cyclo/Phenyl/Tobra/Flurb||(1/1/10/0.3/0.3)%||3 mL vial||05202014@3||11/16/2014|
We are voluntarily recalling the products as a precautionary measure, out of an abundance of caution and in order to ensure the public health and the safety of our patients.
Pharmacy Creations has notified all affected customers and has arranged for the return of the recalled product lots. Physicians and patients that have products which are being recalled should stop use and return to place of purchase.
Customers with questions regarding this recall can contact Pharmacy Creations by mail at 540 Route 10 West Randolph, NJ 07869 or call (858) 366-8389, Monday through Friday, 8 A.M. to 5 P.M, Eastern Standard Time. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
- Complete and submit the report Online: www.fda.gov/medwatch/report.htm
- Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.