Drug product
Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:1, Wedgewood Village Pharmacy LLC, 405 Heron Dr. Ste 200, Swedesboro, NJ 08085
D-1181-2022
Product summary
- Event
- Event 90403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 suspension bottle
- Official record key
drug-enforcement:D-1181-2022
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Code information: Lot #: 000-03715131, Exp Date: 07/19/22
Distribution pattern: Products were distributed nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls