FDA (Drugs) recall action 95430
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.
Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.
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.
Denison Pharmaceuticals recalls Maximum Strength Cough and Chest Congestion and Nighttime Severe Cold and Flu Combo Pack due to crystallization and texture changes in affected bottles.
Denison Pharmaceuticals is recalling its Maximum Strength Cough and Chest Congestion medication due to crystallization in bottles. The product, distributed by Genexa Inc., may contain chunks, graininess, or crystal substances that affect uniformity.