Safe Tussin PM Night Time Cough Relief Recalled for Manufacturing Deviation
Kramer Laboratories is recalling Safe Tussin PM Night Time Cough Relief due to use of non-food-grade lubricant in the mixing vessel during manufacturing. Affected product: lot 8639, expiration 8/2023, distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 for a manufacturing deviation involving contamination with non-food-grade lubricant in a drug product. No illnesses or injuries have been reported, but the potential exists for patient harm from ingestion of the foreign substance, placing this in the risk-of-harm category without reported injury.
Plain-English summary
Kramer Laboratories, Inc. is recalling Safe Tussin PM Night Time Cough Relief (Cough Suppressant/Antihistamine) packaged in 4.0 FL OZ (118 mL) bottles. The recalled product includes lot 8639 with an expiration date of August 2023.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. Non-food-grade lubricant was used in the mixing vessel during manufacturing, which could potentially contaminate the product.
The product was distributed nationwide within the United States. Consumers who have this product should stop using it and dispose of it safely or return it to the point of purchase.
The recalled product
- 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
- Manufacturer
- Kramer Laboratories, Inc.
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. Date 8/2023
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Kramer Laboratories, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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