Drug product
Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate 200mcg/Glutamine (L) 30mg/Arginine HCL 200mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
D-0322-2017
Product summary
- Event
- Event 75763
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 870 vials
- Official record key
drug-enforcement:D-0322-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: Recall includes all sterile products compounded between 05/17/2016 and 11/17/2016. Known lot codes (Exp Date): 05232016B (11/19/2016), 07272016C (11/30/2016), 07152016H (11/30/2016), 09152016B (12/31/2016), 11022016B (05/01/2017), 06082016B (11/30/2016), 08172016C (12/31/2016), 10202016C (02/28/2017).
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility