Recalls / Class II
Class IID-740-2013
Product
HCG 125iu/0.25ml (550iu/ml), 3500iu and 10,000iu, compounded by Olympia Pharmacy, Orlando, FL
- Affected lot / code info
- 500iu Lot A3504 Exp 8/31/13 3500iu Lot C3105 Exp 9/5/13 10000 iu Lot C3611 Exp 9/6/13
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
- 3
- 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-740-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.