Drug product
Liver Derivative Complex for injection, each mL contains: Liver Derivative Complex 25.5mg, also contains: Water for Injection, Phenol 0.5%, HCl or NaOH to adjust pH, 10 mL, Compounded by Prescription: JOHN HOLLIS Pharmacist Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1389-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1560 mL
- Official record key
drug-enforcement:D-1389-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: Lot# 938, Use by 08/17/14, Lot #1370; Use by Lot# 1818; Use by 11/08/14, 1/30/15; Lot# 2664, Use by 4/18/15
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility