Drug product
Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN 38485, NDC 00000-0001-07
D-0416-2019
Product summary
- Event
- Event 81811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2700 cc
- Official record key
drug-enforcement:D-0416-2019
Official wording
Reason: Lack of Processing Controls.
Code information: N/A
Distribution pattern: TN only
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls