Drug product
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.
D-1041-2018
Product summary
- Event
- Event 80662
- Status
- Terminated
- Classification
- Class III
- Quantity
- 306 cartons
- Official record key
drug-enforcement:D-1041-2018
Official wording
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Code information: Lot #: NBBN, Exp 02/22
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Labeling or packaging
Labeling: Incorrect or Missing