FDA Drug recall D-1041-2018
Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instruct…
- FDA Drug
- Class III
- terminated
- Published 2018-08-15
On 2018-08-15 the FDA classified a Class III recall of Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instruct… by Valeant Pharmaceuticals North America, citing labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1041-2018 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2018-07-10 |
| Published | 2018-08-15 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Valeant Pharmaceuticals North America |
| Distribution | US |
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
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Identifiers
| ndc | 68682-652-20 |
|---|---|
| ndc | 68682-655-20 |
| ndc | 68682-650-20 |
| code_info | Lot #: NBBN, Exp 02/22 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1041-2018%22
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