Safe tussin PM recall: CGMP Deviations
Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer…
Why was Safe tussin PM recalled?
CGMP Deviations: Use of non-food grade lubricant in mixing vessel.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot 8639, Exp: 8/2023
- Product
- Safe tussin PM, NIGHT TIME Cough Relief, (Dextromethorphan HBr, USP 7.5mg, Doxylamine Succinate 3.125mg), 4.0 FL OZ (118mL) bottle, Kramer…
- Recalling firm
- Denison Pharmaceuticals, LLC
- Quantity
- 13,968 bottles
- Distribution
- Product was distributed Nationwide.
- Recall date
- June 7, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)