FDA recall D-791-2013

Lowlite Investments, Inc. D/B/A Olympia Pharmacy · Class II · drug

Product

Vitamin B12 (3000 mcg/ml & 5000 mcg/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

Distribution

Nationwide and PR

Key facts

Status
Ongoing
Initiation date
2013-05-29
Report date
2013-07-17
Voluntary/Mandated
Voluntary: Firm initiated
Location
Orlando, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-791-2013