Drug product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc, 110 20th Avenue N, Nashville, TN 37203 615-327-3234
D-1403-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 40 mL
- Official record key
drug-enforcement:D-1403-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: a) 5 mL: Lot: 2670 best used by 7/02/14; Lot 2855, best used by 7/15/14; b) 10 mL: Lot: 2303, best used by 6/04/14; Lot: 2343, best used by 6/08/14; Lot: 2600, best used by 6/29/14;
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility