FDA (Drugs) recall action 88976
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.
cGMP Deviations: Product manufactured with contaminated raw ingredient.
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.
Precision Dose Inc. is recalling Acetaminophen Oral Suspension (325 mg/10.15 mL) due to contaminated raw ingredient used in manufacturing. The recall affects 151,100 unit dose cups distributed nationwide for hospital use.
Precision Dose Inc. is recalling 166,920 unit dose cups of Acetaminophen Oral Suspension 160 mg/5 mL (Lot 503670) distributed nationwide due to cGMP deviations involving contaminated raw ingredient used in manufacturing.