Pentrexcilina Tablets Recalled for Misleading Labeling Confusion
OPMX, LLC is recalling Pentrexcilina tablets because the labels are misleading and may be confused with a prescription antibiotic.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error that could lead to medication confusion, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
OPMX, LLC is recalling Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets. The recall involves 11,580 cartons of 20-count tablets distributed nationwide. The specific lot number is 11611B0, batch number is 114039, and the expiration date is 10/14. The product is distributed by Laboratorios Norimex Co. in San Diego, CA.
The recall was initiated because the product labels are misleading. Specifically, the labels may cause consumers to confuse Pentrexcilina with Pentrexyl, which is a prescription antibiotic used to treat respiratory illnesses in Mexico. This confusion poses a risk of improper medication use.
Consumers who have purchased these specific tablets should stop using them and contact the recalling firm or their healthcare provider for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- 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.
- Manufacturer
- OPMX, LLC
- Affected units
- 11,580
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 11611B0
- Batch # 114039
- Exp 10/14
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by OPMX, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · OPMX, LLC
See all →- ModeratePentrexcilina Liquid Recalled for Misleading Labeling Confusion with Prescription Antibiotic
FDA (Drugs) · 2013-05-01
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