The Recall Desk

FDA (Drugs) recall action 86264

Ultra Seal Corporation recalled 2 products on 2020-08-26

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
2020-08-26
Critical
0
Units
5,368,090

Why these products were recalled

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

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

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–2 of 2

  • LowFDA (Drugs)··2020-08-26

    Ultra Seal Recalls Extra Strength Headache Relief Tablets for Stability Failures

    Ultra Seal Corporation is recalling 701,735 packets of Extra Strength Headache Relief tablets due to out-of-specification results for salicylic acid.

    Product
    Extra Strength Headache Relief (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablet packets, Manufactured for: Convenience Valet Glendale Heights, IL 60139,
    Category
    Distribution
    2 states
  • LowFDA (Drugs)··2020-08-26

    Ultra Seal Recalls Pain Relief Tablets Due to Stability Failures

    Ultra Seal Corporation is recalling specific lots of Pain Relief Maximum Strength tablets because they failed stability specifications for salicylic acid.

    Product
    Pain Relief Maximum Strength (Acetaminophen 250 mg/aspirin 250 mg/Caffeine 65 mg) tablets, 2-tablets per packet, Manufactured for Select Corporation, Carrollton, TX 75007
    Category
    Distribution
    2 states