The Recall Desk

Hazard

Assay Out Of Specification recalls

1 recall in our database tag this hazard, drawn from FDA, USDA FSIS, CPSC, and NHTSA source notices.

What the numbers show

Total
1
Critical
0
Severe
0
Most recent
2015-10-21

Of the 1 assay out of specification recalls we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this hazard tag

Hazard tags are short, machine-readable labels we attach to every recall to make cross-cutting queries possible — “all assay out of specification recalls regardless of agency”, “all listeria recalls in California”, “all airbag recalls in 2025”. The tags are extracted from each recall’s source text during the LLM rewrite step and validated against a fixed schema.

A recall can carry multiple tags — a Listeria recall might also be tagged ready-to-eat and undeclared-allergen. Use the full-text search if you want to combine hazard tags with brand or category filters.

1–1 of 1

  • LowFDA (Drugs)·D-0026-2016·2015-10-21

    Fred's Loratadine Tablets Recalled for Out-of-Specification Assay Results

    Ohm Laboratories is recalling Fred's Loratadine Orally Disintegrating Tablets due to an out-of-specification assay result. The FDA classifies this as a Class III recall.

    Product
    Fred's Loratadine Orally Disintegrating Tablets, USP, 10 mg, 30-counts tablets per box, Distributed by: fred's, Inc., 4300 New Getwell Road, Memphis, TN 38118, UPC 0 8457912198 4.
    Category
    Drug
    Distribution
    Distributed nationwide