D-784-2013 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- July 17, 2013
- Initiation Date
- May 29, 2013
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2
Product Description
Tacrolimus (0.02% and 0.03%) drops, 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 Pattern
Nationwide and PR
Code Information
C51012 Exp 9/12/13 and C51201 Exp 9/6/13