Drug product
Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's Health Mart Pharmacy 215 Dexter Woods Blvd. Waynesboro, TN38485, NDC 00002-1901-03
D-0419-2019
Product summary
- Event
- Event 81811
- Status
- Terminated
- Classification
- Class II
- Quantity
- 876 cc
- Official record key
drug-enforcement:D-0419-2019
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