The Recall Desk

FDA (Drugs) recall action 92407

Kramer Laboratories, Inc. recalled 2 products on 2023-08-02

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2023-08-02
Critical
0
Units
—

Why these products were recalled

CGMP Deviations: use of non-food grade lubricant in mixing vessel.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2023-08-02

    Safe Tussin DM Cough Suppressant Recalled for Manufacturing Deviation

    Kramer Laboratories is recalling Safe Tussin DM Cough + Chest Congestion due to a manufacturing deviation involving non-food grade lubricant in the mixing vessel. Affected lots 8753, 8753A, and 8659 were distributed nationwide.

    Product
    Safe Tussin DM Cough + Chest Congestion (Dextromethorphan HBr/ Cough Suppressant Guaifenesin/Expectorant), packaged in 4.0 FL OZ(118mL), 2020 Kramer Laboratories, Inc. Bridgewater, NJ 08807
    Category
    Distribution
    0 states
  • HighFDA (Drugs)··2023-08-02

    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.

    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
    Category
    Distribution
    0 states