Drug product
NADH/Carnitine/Taurine/B12(M) Injectable, 100 mg/150 mg/150 mg/10 mg, Lyophilized Kit, Compounded by Wells Pharmacy, Ocala, FL
D-0381-2017
Product summary
- Event
- Event 75289
- Status
- Terminated
- Classification
- Class II
- Quantity
- 219 kits (number of vials per kit vary by prescription)
- Official record key
drug-enforcement:D-0381-2017
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 kit lot code: 04072016@29, 08122016@103. Known vial lot code: 03302016@13, 03252016@16, 08082016@58, 08082016@67.
Distribution pattern: Nationwide
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility