Recalls / Class II

Class IID-765-2013

Product

Papaverine 40 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL

Affected lot / code info

B0021 Exp 8/31/13, B0013 Exp 8/1/13, C5122 Exp 9/22/13, C51101 Exp 8/1/13, C5508 Exp 9/8/13, and C5119 Exp 9/19/13

Why it was recalled

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

Recalling firm

Firm

Lowlite Investments, Inc. D/B/A Olympia Pharmacy

Notification channel

Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Type

Voluntary: Firm initiated

Address

6700 Conroy Windermere Rd, Suite 140, Orlando, Florida 32835-3500

Distribution

Quantity

6

Distribution pattern

Nationwide and PR

Timeline

Recall initiated

2013-05-29

FDA classified

2013-07-11

Posted by FDA

2013-07-17

Status

Ongoing

Source: openFDA Drug Enforcement endpoint. Recall record D-765-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.