Drug product
PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Chloride, Water, Hydrochloric Acid, and/or Sodium Hydroxide, 30 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1405-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 30 mL
- Official record key
drug-enforcement:D-1405-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: Lot: 2789, Best used by: 7/10/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility