# FDA recall D-1041-2018

> **Valeant Pharmaceuticals North America LLC** · Class III · drug recall initiated 2018-07-10.

## 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.

## 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.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-1041-2018
- **Recalling firm:** Valeant Pharmaceuticals North America LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-07-10
- **Report date:** 2018-08-15
- **Termination date:** 2019-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Bridgewater, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1041-2018

## Citation

> AI Analytics. FDA recall D-1041-2018. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-1041-2018. Source: US FDA. Licensed CC0.

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