Drug product
QUAD2 (PAP/PHEN/ALPROS/ATRO) 9 mg/1 mg/10 mg/0.1 mg/mL Injectable a) 2 mL and b) 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0384-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- a) 191 vials and b) 794 vials
- Official record key
drug-enforcement:D-0384-2017
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: 04222016@8, 06142016@42, 08152016@17 b) Known lot code: 03312016@8, 05182016@15, 08092016@18
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility