Advocacy & Practice Updates — Advocacy & Practice
FDA Alert: Pharmacy Creations Recalls Tropi/Cyclo/Phenyl/Tobra/Flurb
The US Food and Drug Administration (FDA) has announced that Pharmacy Creations (Randolph, NJ) has voluntarily recalled Tropi/Cyclo/Phenyl/Tobra/Flurb, (1/1/10/0.3/0.3)%, 3 mL vial, lot number 05202014@3, with an expiration date of 11/16/2014.
According to the FDA, the recall was initiated after test results indicated that the product lot may have the potential of not being sterile. To date, there have been no reported adverse events associated with the use of the product.
The recalled preparation was distributed in Florida, New Jersey, New York, and Puerto Rico between March 4, 2014 and June 18, 2014 and was mailed directly to physicians and patients.
If you have any of the recalled product lot, you are advised to stop use and return it to the place of purchase.
Should you have questions regarding this recall, please contact Pharmacy Creations by mail at 540 Route 10 West, Randolph, NJ 07869 or call 858-366-8389, Monday through Friday between 8:00 AM and 5:00 PM EDT. Consumers should contact their physician if they have experienced any problems that may be related to taking or using this drug product.
To report an adverse event or side effect:
- Download the form or call 800-332-1088 to request the reporting form. Complete and return it to the address on the form, or fax to 800-FDA-0178.
Updated September 7, 2014