Lowlite Investments, Inc. d/b/a Olympia Pharmacy Announces a Voluntary Multi-State Recall of All Sterile Compounded Products Compounded Between December 17, 2012, and March 27, 2013, Due to Concerns About Sterility Assurance

Date of Recall

2013-05-29

Recall Details

- May 29, 2013 - Lowlite Investments d/b/a Olympia Pharmacy ("Lowlite") today announced 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. To date, Lowlite has received no reports of injury or illness associated with the use of our sterile products. This voluntary recall is being conducted as a precautionary measure to ensure the sterility of our sterile products, and is being conducted with the full knowledge of the FDA.

Patients should experience little to no disruption in their pharmacy services as a result of this recall.

The recall includes all sterile products that Lowlite supplied to patients and offices of licensed medical professionals with a use by date of 09/25/2013 or earlier. A list of products is attached. Lowlite will be notifying customers by phone, fax, or mail to return the products to the pharmacy.

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: [email protected]. Patients who have received any product furnished by Lowlite and have concerns should contact their healthcare provider.

Adverse reactions or quality problems experienced with the use of any Lowlite products may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.

• Online: www.fda.gov/medwatch/report.htm
• Regular mail: use postage-paid, pre-addressed Form FDA 3500 available at:
  www.fda.gov/MedWatch/getforms.htm
  Mail to address on the pre-addressed form
• Fax: 1-800-FDA-0178

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