FDA Recall D-704-2013
Lowlite Investments, Inc. D/B/A Olympia Pharmacy · Orlando, FL
Class II Ongoing 4733 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Betamethasone Sodium Phosphate 12 mg/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
Recall record
- Recall number
D-704-2013- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Distribution
- Nationwide and PR
- Recall initiated
- 2013-05-29
- Classified by FDA Center
- 2013-07-11
- FDA published
- 2013-07-17
- Recalling firm
- Lowlite Investments, Inc. D/B/A Olympia Pharmacy
- Firm location
- Orlando, FL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.