Recalls / Class II

Class IID-773-2013

Product

Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmacy, Orlando, FL

Affected lot / code info

0.75% Lot L5611 Exp 11/30/13 // 1% Lot b3001 Exp 6/19/13, B5014 Exp 8/14/13, and A5431 Exp 6/4/13 // 3% Lot A5808 Exp 12/31/13 // 10% Lot C5328 Exp 9/3/13

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-773-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.