Drug product
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1401-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 mL
- Official record key
drug-enforcement:D-1401-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: Lot: 2187, best used by 05/26/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility