FDA Drug recall D-0775-2023
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer…
- FDA Drug
- Class II
- ongoing
- Published 2023-06-07
On 2023-06-07 the FDA classified a Class II recall of Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer… by Denison Pharmaceuticals, citing CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0775-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2023-05-03 |
| Published | 2023-06-07 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Denison Pharmaceuticals |
| Distribution | US |
Product
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer Laboratories , Inc. Bridgewater, NJ 08807.
Reason
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
Identifiers
| code_info | Lot 8639, Exp: 8/2023 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0775-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.