PlainRecalls
FDA Drug Moderate Class II Ongoing

Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Reported: July 17, 2013 Initiated: May 29, 2013 #D-762-2013

Product Description

Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Reason for Recall

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

Details

Units Affected
1
Distribution
Nationwide and PR
Location
Orlando, FL

Frequently Asked Questions

What product was recalled?
Naproxen 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL. Recalled by Lowlite Investments, Inc. D/B/A Olympia Pharmacy. Units affected: 1.
Why was this product recalled?
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Which agency issued this recall?
This recall was issued by the FDA Drug on July 17, 2013. Severity: Moderate. Recall number: D-762-2013.