Key Takeaway
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL by Lowlite Investments, Inc. D/B/A Olympia Pharmacy was recalled on May 29, 2013. The hazard: Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Description
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
Hazard / Reason
Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes
Class II: Product that may cause temporary or medically reversible health consequences.
Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.
Products Affected
Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL
DrugsCompany Information
Lowlite Investments, Inc. D/B/A Olympia Pharmacy
Orlando, FL, United States
View all 105 recalls by Lowlite Investments, Inc. D/B/A Olympia Pharmacy →Distribution
Nationwide and PR
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Frequently Asked Questions
Is this recall still active?
Check the status badge at the top of this page. "Ongoing" means the recall is still active and you should follow the remedy instructions. "Completed" or "Terminated" means the recall process has concluded, though the safety issue remains relevant for any unrepaired products.
How do I check if my product is affected?
Compare the model number, lot code, serial number, or date range listed in the recall notice with the information on your product's label or packaging. For vehicles, check your VIN at NHTSA.gov/Recalls.
What remedy is available for this recall?
Check the remedy section above or contact the manufacturer directly for current remedy options.
Where can I find the original recall notice?
This recall was issued by FDA Drug. Visit the agency's official website for the original notice.