Drug product
Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN HOLLIS Pharmacist, Inc 110 20th Avenue N, Nashville, TN 37203, 615-327-3234
D-1400-2014
Product summary
- Event
- Event 68557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 170 mL
- Official record key
drug-enforcement:D-1400-2014
Official wording
Reason: Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled injectable products.
Code information: a) 5 mL: Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14; Lot: 2672, best used by 7/03/14; Lot: 3022, best used by 7/28/14; b) 10 mL: Lot: 2166, best used by 5/26/14; Lot: 2297, best used by 6/04/14; Lot: 2578, best used by 6/25/14
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility