Drug product
Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
D-1185-2022
Product summary
- Event
- Event 90403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 tube
- Official record key
drug-enforcement:D-1185-2022
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Code information: Lot#: 000-03807142 Exp Date: 08/27/22
Distribution pattern: Products were distributed nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls