Drug product
Lipo-Injection w/ Lidocaine (PF), Ascorbic Acid 50 mg; B1-50 mg; B2-5-PO4-5 mg; B3-50 mg; B5-5 mg; B6-5 mg; Cyano B12-100 mcg; Methionine 12.5 mg; Inositol-25 mg; Choline-25 mg; Lidocaine 10 mg/mL, 30 mL, Medaus Pharmacy 1-800-526-9183
D-1049-2013
Product summary
- Firm
- Medaus, Inc.
- Event
- Event 66172
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19,803 mL
- Official record key
drug-enforcement:D-1049-2013
Official wording
Reason: Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Code information: Lot #: 130510-26, Exp 11/16/2013; 130610-24, Exp 12/7/2013; and 130709-68, Exp 1/5/2014
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
microbial contamination
-
Sterility assurance
Lack of Assurance of Sterility