Status
Terminated
Drug Enforcement D-300-2013
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.
Classification
Class II
Report Date
May 1, 2013
Termination Date
August 22, 2013
Product Information
- Product description
- 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.
- Product quantity
- 7,610 bottles
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide
Location & Firm
- Recalling firm
- OPMX, LLC
- Address
-
6225 Progressive Dr, # 200
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-300-2013
- Event ID
- 64933
- Recall initiation date
- April 12, 2013
- Center classification date
- April 25, 2013
- Code info
- Lot #: 11649A0, Exp 12/13
- More code info
- —