Status
Terminated
Drug Enforcement D-299-2013
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 (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.
- Product quantity
- 11,580 cartons
- 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-299-2013
- Event ID
- 64933
- Recall initiation date
- April 12, 2013
- Center classification date
- April 25, 2013
- Code info
- Lot #: 11611B0, Batch # 114039, Exp 10/14
- More code info
- —