  |
Sterile Human and Veterinary Compounded Drugs by Moses Lake Professional Pharmacy: Recall - Lack of Sterility Assurance
AUDIENCE: Health Professional, Pharmacy, Veterinary, Patient
ISSUE: Moses Lake Professional Pharmacy is voluntarily recalling human and veterinary sterile compounded drugs which are unexpired to the consumer level due to lack of sterility assurance.The company has not received any reports of product contamination or adverse events to date, and is issuing this voluntary recall out of an abundance of caution following a recent inspection which identified an issue with sterility assurance. If there is contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
BACKGROUND: The recalled products were made from 7/21/2014 through 7/21/2015, and dispensed to patients or distributed to physicians for further administering to patients in the states of Arizona, Idaho, Florida, Oregon, Texas, and Washington. All recalled products have a label that includes the pharmacy name and the name of the compounded drug product. The recall does not pertain to any non-sterile compounded medications prepared by the pharmacy or to products compounded after July 21, 2015.
For a table to the sterile compounded products subject to the recall, see the Firm Press Release.
RECOMMENDATION: The pharmacy has begun notifying its patients by telephone, fax, electronic mail and/or regular mail of this recall. Users or recipients of these products should immediately discontinue use and return the recalled unexpired products. To return product or request assistance related to this recall, users should call 509-764- 2314, Monday through Friday, from 8:30 a.m. to 12:30 p.m. and 1 to 5:30 p.m. PDT.; Consumers should contact their physician or health care provider if they have experienced any problems that may be related to taking these drug products.
The FDA asks health care providers and consumers to report adverse events or quality problems experienced with the use of any products to the FDA’s MedWatch Adverse Event Reporting program:
- Complete and submit the report online at www.fda.gov/medwatch/report.htm
- Download and complete the form, then submit it via fax at 1-800-FDA-0178
Read the MedWatch Safety Alert, including a link to the Firm Press Release at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm455931.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your email address to log in. If you have questions or problems with the subscription service, please visit subscriberhelp.govdelivery.com.
This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).
| This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420 |  |
