Recalls / Class III
Class IIID-1041-2018
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.
- Brand name
- Diazepam
- Generic name
- Diazepam
- Active ingredient
- Diazepam
- Route
- Rectal
- NDCs
- 68682-650, 68682-652, 68682-655
- FDA application
- NDA020648
- Affected lot / code info
- Lot #: NBBN, Exp 02/22
Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Recalling firm
- Firm
- Valeant Pharmaceuticals North America LLC
- Manufacturer
- Oceanside Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 400 Somerset Corporate Blvd, N/A, Bridgewater, New Jersey 08807-2867
Distribution
- Quantity
- 306 cartons
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2018-07-10
- FDA classified
- 2018-08-03
- Posted by FDA
- 2018-08-15
- Terminated
- 2019-02-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1041-2018. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.