FDA Drug recall D-0943-2023
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc
- FDA Drug
- Class II
- terminated
- Published 2023-08-02
On 2023-08-02 the FDA classified a Class II recall of Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc by Kramer Laboratories, citing CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0943-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-06-23 |
| Published | 2023-08-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Kramer Laboratories |
| Distribution | US |
Product
Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine), packaged in 4.0 FL OZ(118mL) bottles, Kramer Laboratories, Inc. Bridgewater, NJ 08807
Reason
CGMP Deviations: use of non-food grade lubricant in mixing vessel.
Identifiers
| code_info | Lot #: 8639, Exp. Date 8/2023 |
|---|
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-0943-2023%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.