D-757-2013 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
Methylcobalamin 25 mg/ml Inj and 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 Pattern
Nationwide and PR
Code Information
25mg/ml Inj Lot L3620 Exp 12/31/13 5000mcg/ml Inj Lot A3328 Exp 6/28/13