The Recall Desk
HighFDA (Drugs)·D-0775-2023·Announced 2023-06-07

Cough Relief Medication Recalled for Non-Food Grade Lubricant Manufacturing Defect

Denison Pharmaceuticals is recalling Safe tussin PM nighttime cough relief due to use of non-food grade lubricant during manufacturing. Consumers should stop use and consult a pharmacist.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with a manufacturing defect involving the use of non-food grade lubricant. No illnesses or injuries are reported. It qualifies as a risk-of-harm product without reported injury, warranting a High severity score.

Plain-English summary

Denison Pharmaceuticals, LLC is recalling Safe tussin PM, NIGHT TIME Cough Relief (Dextromethorphan HBr 7.5 mg, Doxylamine Succinate 3.125 mg) in 4 FL OZ bottles due to a Current Good Manufacturing Practice (CGMP) deviation. A non-food grade lubricant was used in the mixing vessel during manufacturing.

The recalled product is Lot 8639 with an expiration date of August 2023. The product was distributed nationwide. Approximately 13,968 bottles are affected.

Consumers who have used this product should consult with a pharmacist or healthcare provider.

The recalled product

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.
Manufacturer
Denison Pharmaceuticals, LLC
Category
Drug — Nighttime Cough Relief
Hazard
  • cgmp-violation
  • lubricant-contamination

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot 8639
  • Exp: 8/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category