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.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: NBBN, Exp 02/22
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1041-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 10, 2018
- FDA report date
- Aug 15, 2018
- Quantity
- 306 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Valeant Pharmaceuticals North America LLC
Original FDA data
Every field from FDA enforcement report D-1041-2018, exactly as published.
Show all FDA fields
- City
- Bridgewater
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 80662
- Address
- 400 Somerset Corporate Blvd
- Code information
- Lot #: NBBN, Exp 02/22
- Postal code
- 08807-2867
- Report date
- Aug 15, 2018
- Product type
- Drugs
- Recall number
- D-1041-2018
- Classification
- Class III
- Recalling firm
- Valeant Pharmaceuticals North America LLC
- Product quantity
- 306 cartons
- Termination date
- Feb 5, 2019
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jul 10, 2018
- Initial firm notification
- Letter
- Center classification date
- Aug 3, 2018