CLASS II Drug recall · Reported 1 May 2013 · FDA Enforcement Report
Pentrexcilina (acetaminophen, chlorpheniramine maleate recalled by OPMX
OPMX is recalling Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets, distributed nationwide in the US. The recall was initiated on 12 Apr 2013 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-299-2013
- FDA event ID
- 64933
- Recalling firm
- OPMX, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 12 Apr 2013
- FDA classified
- 25 Apr 2013
- Reported
- 1 May 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Pain Medication
Timeline
| 12 Apr 2013 | Recall initiated by company | |
| 25 Apr 2013 | Classified by FDA | +13 days |
| 1 May 2013 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
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.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Is Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets recalled?
Yes. OPMX recalled Pentrexcilina (acetaminophen, chlorpheniramine maleate, and phenylephrine HCl) tablets on 12 Apr 2013. The recall is Class II and its status is Terminated. Recall number D-299-2013.
Why was it recalled?
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.
Which lots are affected?
Lot #: 11611B0, Batch # 114039, Exp 10/14
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from OPMX
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pentrexcilina Jarabe NF (dextromethorphan HBr recalled by OPMX | OPMX | Other | Nationwide |