Drug product
LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Riboflavin-5 phosphate 5mg, Niacinimide 50mg, Calcium Pantothenate 5 mg, Cyanocobalamin 1mg, Methionine 12.5mg, Choline 25mg, Inositol 25 mg, Sterile Water For injection, JOHN HOLLIS Pharmacist, Inc,110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1404-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 mL
- Official record key
drug-enforcement:D-1404-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: lot: 2571, use by 9/23/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility