Vivelle-Dot FDA Alerts
The FDA Alerts below may be specifically about Vivelle-Dot or relate to a group or class of drugs which include Vivelle-Dot.
MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings.
Jump to date
Recent FDA Alerts for Vivelle-Dot
Olympia Pharmacy Sterile Compounded Products: Recall - Concerns About Sterility Assurance
[Posted 05/30/2013]
ISSUE: Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") notified the public of a voluntary multi-state recall of all sterile drug products compounded by the pharmacy that have not reached the expiration date listed on the product. The recall is being initiated due to concerns associated with prior quality control procedures that impacted sterility assurance. In the event a sterile product is compromised patients are at risk for serious and possible life threatening infections.
The recall includes all sterile products that Olympia Pharmacy supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. Olympia Pharmacy will be notifying customers by phone, fax, or mail to return the products to the pharmacy.
BACKGROUND: To date, Lowlite has received no reports of injury or illness associated with the use of the affected products.
RECOMMENDATION: Consumers or health care providers with questions regarding this recall may contact Lowlite by phone at 888-323-7788 or 407-673-2222 from the hours of 9:00AM- 6:00PM Eastern Daylight Time Monday through Friday, or at the following e-mail address: Brian@olympiapharmacy.com. Patients who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form 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
[05/30/2013 - Press Release - Olympia Pharmacy]
[05/30/2013 - Recalled Product List - Olympia Pharmacy]
Transdermal Drug Patches with Metallic Backings: Risk of Burns during MRI Scans
[Posted 03/05/2009] FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.[March 05, 2009}
Injectable drugs prepared by Urgent Care Pharmacy
The Food and Drug Administration (FDA) announced a nationwide alert concerning all injectable drugs prepared by Urgent Care Pharmacy of Spartanburg, South Carolina, based on the lack of assurance that their products are sterile. Non-sterility of injectable products can represent a serious hazard to health that could lead to life-threatening injuries and death. FDA inspection of Urgent Care's facility revealed the firm failed to have adequate controls to ensure necessary sterility, including the absence of appropriate testing for potency and sterility prior to distribution.FDA is aware that Urgent Care has distributed the following injectable drugs to physicians, hospitals, clinics and consumers in Connecticut, Illinois, Indiana, Kentucky, Louisiana, Massachusetts, Mississippi, New Hampshire, North Carolina, South Carolina and Virginia: Baclofen, Betamethasone, Bimix 30:1, (Phentolamine mesylate/papaverine), Clonidine, Estradiol, Hydromorphone HCl, Fentanyl, methylprednisolone acetate, Morphine Sulfate/Bupivacaine, Papaverine HCl, Super Trimix (Papaverine HCl/phentolamine mesylate/prostaglandin), Testosterone cypionate, Testosterone/Estradiol.
[November 15, 2002 Talk Paper - FDA]