Drug product
Phenylephrine HCl Injectable, 1 mg/mL (0.1%), 5 mL vial, Compounded by Wells Pharmacy, Ocala, FL
D-0331-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,968 vials
- Official record key
drug-enforcement:D-0331-2017
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. Known lot codes: 03292016@3, 04202016@4, 05162016@6, 06102016@9, 07202016@44, 08032016@38
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility