Pentrexcilina Tablets (OPMX) – Misleading Labeling (2013)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tablets per carton, Distributed by: Laboratorios Norimex Co., San Diego, CA 92154, UPC 0 91965 02002 8.
Brand
OPMX, LLC
Lot Codes / Batch Numbers
Lot #: 11611B0, Batch # 114039, Exp 10/14
Products Sold
Lot #: 11611B0, Batch # 114039, Exp 10/14
OPMX, LLC is recalling Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, 20-count tab due to Labeling: Not Elsewhere Classified: Pentrexcilina Tablets and Pentrexcilina Liquid are being recalled because the product labels are misleading becaus. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026