Drug product
Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1399-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 45 mL
- Official record key
drug-enforcement:D-1399-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: a) 5 mL: Lot: 2543, best used by 3/24/14; Lot: 2137, best used by 5/25/14; Lot 3056, best used by 7/30/14; Lot: 3081, best used by 8/04/14; b) 10 mL: Lot: 2194, best used by 5/26/14; Lot: 2950, best used by 7/22/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility