The Recall Desk
LowFDA (Drugs)·D-1041-2018·Announced 2018-08-15

Valeant Recalls Diazepam Rectal Gel Due to Missing Lot and Expiration Dates

Valeant Pharmaceuticals is recalling 306 cartons of Diazepam Rectal Gel because the outer cartons are missing lot numbers and expiration dates.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a violation of labeling or manufacturing regulations that is not likely to cause adverse health consequences. The hazard is limited to missing documentation on the packaging.

Plain-English summary

Valeant Pharmaceuticals North America LLC is recalling 306 cartons of Diazepam Rectal Gel, 2.5 mg, TWIN PACK. The product is a prescription-only medication manufactured for Oceanside Pharmaceuticals and distributed nationwide in the USA. The specific lot affected is NBBN with an expiration date of 02/22.

The recall was initiated because the product was distributed without a lot number or expiration date on the outer carton. This labeling error prevents proper identification and tracking of the specific product units.

Consumers and healthcare providers should check their inventory for Diazepam Rectal Gel, 2.5 mg, TWIN PACK (NDC 68682-650-20) with Lot NBBN and Exp 02/22. If the outer carton is missing these identifiers, the product should be returned to the supplier or disposed of according to local regulations.

The recalled product

Product
DIAZEPAM (DIAZEPAM)
Brand
DIAZEPAM
Affected units
306

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: NBBN
  • Exp 02/22

Distribution

Distributed nationwide across the United States.

Same manufacturer · Valeant Pharmaceuticals North America LLC

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