Drug 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.
D-300-2013
Product summary
- Firm
- OPMX, LLC
- Event
- Event 64933
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,610 bottles
- Official record key
drug-enforcement:D-300-2013
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 #: 11649A0, Exp 12/13
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.