Drug product
QUAD1(PAP/PHEN/ALPROS/ATRO) 0.9 mg/0.2 mg/20 mcg/0.01 mg/mL Injectable, a) 2 mL and b) 5 mL vials, Compounded by Wells Pharmacy, Ocala, FL
D-0383-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 1,165 vials b) 2,217 vials
- Official record key
drug-enforcement:D-0383-2017
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lot codes of product prepared between 02/22/2016 and 09/14/2016, within expiry. a) Known lot code: 04122016@17, 04142016@14, 05112016@23, 06072016@17, 06232016@13, 07122016@41, 08052016@12 b) Known lot code: 03242016@8, 04142016@15, 05032016@11, 05262016@12, 06242016@11, 07122016@42, 08052016@11.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility