Drug 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.
D-299-2013
Product summary
- Firm
- OPMX, LLC
- Event
- Event 64933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 11,580 cartons
- Official record key
drug-enforcement:D-299-2013
Official wording
Reason: 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.
Code information: Lot #: 11611B0, Batch # 114039, Exp 10/14
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
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.