FDA (Drugs) recall action 88806
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.
Failed Moisture Limits
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.
SUN PHARMACEUTICAL INDUSTRIES INC is recalling Kirkland Signature AllerClear D 24 HR (Loratadine and Pseudoephedrine Sulfate) tablets nationwide because the product failed to meet moisture content limits.
Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.