ApotheCure and NuVision compounding pharmacies recall all lots of sterile products
The companies' voluntary national recalls are based in sterility assurance concerns
On April 15, 2013, two pharmaceutical compounders recalled their sterile products following an alert issued by FDA.
NuVision Pharmacy, a compounding practice based in Dallas, Texas, instituted a voluntary national recall of all lots of all compounded lyophilized (freeze-dried powder) products, citing sterility assurance concerns.
ApotheCure Inc., also based in Dallas, similarly launched a voluntary nationwide recall of all lots of all sterile products compounded, repackaged, and distributed by the company, again for sterility assurance reasons.
Neither NuVision nor ApotheCure has received any reports of illness associated with the use of their products. However, because patients who take compromised sterile products risk serious and possibly life-threatening infections, the companies opted to move forward with the recalls “out of an abundance of caution and in the interest of our patients,” as both companies announced in press statements.
Customers of NuVision will be notified by fax and e-mail, and ApotheCure customers will be instructed by fax, to return any products in their possession to the pharmacy. Patients who have received these products and have concerns should contact their healthcare providers.
Queries concerning the NuVision recall may be made by telephone (800-914-7435) Monday through Friday, 10:00 a.m. to 6:00 p.m. CST, or by e-mail (pharmacist@nuvisionpharmacy.com).
Questions pertaining to the ApotheCure recall may be made by telephone (800-969-6601 / 972-960-6601) between the hours of 9:30 a.m. and 6:00 p.m. or by e-mail (pharmacist@apothecure.com).
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.fda.gov/MedWatch/report.htm
- 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
