Valeant Pharmaceuticals North America LLC recalls Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricatin…

Recall date

July 10, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-1041-2018

FDA classification

Class III

Brand / firm

Valeant Pharmaceuticals North America LLC

Sold / distributed

Nationwide in the USA

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.

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.