Denison Pharmaceuticals, LLC 2023-06-07 Health serious FDA
Health · FDA · Recall #FDA-D-0775-2023
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine… Recall
Issued June 7, 2023 · Denison Pharmaceuticals, LLC
In June 2023, Denison Pharmaceuticals, LLC recalled the Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine…, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
What you should do
- 1 Stop using Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Denison Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Denison Pharmaceuticals, LLC
- Category
- Health
- Recall date
- June 7, 2023
- Units affected
- Not reported
- Sold at
- Product was distributed Nationwide.
- Recall number
- FDA-D-0775-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Denison Pharmaceuticals, LLC has 3 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.