FDA (Drugs) recall action 64933
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.
Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading because they may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico.
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.
OPMX, LLC is recalling Pentrexcilina tablets because the labels are misleading and may be confused with a prescription antibiotic.
OPMX, LLC is recalling Pentrexcilina Jarabe NF liquid because its label may be confused with Pentrexyl, a prescription antibiotic.