Pentrexcilina Liquid Recalled for Misleading Labeling Confusion with Prescription Antibiotic
OPMX, LLC is recalling Pentrexcilina Jarabe NF liquid because its label may be confused with Pentrexyl, 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 due to misleading labeling that could lead to confusion with a prescription drug, fitting the criteria for moderate severity involving labeling errors without reported injuries.
Plain-English summary
OPMX, LLC is recalling Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/4 fl oz bottles. The recall involves 7,610 bottles distributed nationwide. The specific lot number is 11649A0 with an expiration date of 12/13.
The recall was initiated because the product labels are misleading and may be confused with Pentrexyl, a prescription antibiotic used to treat respiratory illnesses in Mexico. This confusion poses a risk of incorrect medication use.
Consumers should check their home medicine cabinets for this specific product and lot number. If found, they should stop using the product and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- Pentrexcilina Jarabe NF (dextromethorphan HBr and guaifenesin) liquid, 118 mL/ 4 fl oz bottle, Distributed by Laboratorios Nordimex Co., San Diego, CA 92154, UPC 0 91965 02001 1.
- Manufacturer
- OPMX, LLC
- Category
- Drug — Cough and Cold
- Affected units
- 7,610
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 (2)
- Lot #: 11649A0
- Exp 12/13
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 Tablets Recalled for Misleading Labeling Confusion
FDA (Drugs) · 2013-05-01
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