Drug product
Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewood Village Pharmacy LLC, 405 Heron Drive, Ste 200, Swedesboro, NJ 08085
D-1184-2022
Product summary
- Event
- Event 90403
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14 suppositories
- Official record key
drug-enforcement:D-1184-2022
Official wording
Reason: Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection
Code information: Lot#: 000-03843532 Exp Date: 09/6/22
Distribution pattern: Products were distributed nationwide in the USA.
Derived failure modes
-
Manufacturing or process control
Lack of Processing Controls