Why it was 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.
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.
Lot numbers, UPCs & expiration codes
Lot #: 11649A0, Exp 12/13
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-300-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 12, 2013
- FDA report date
- May 1, 2013
- Quantity
- 7,610 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- OPMX, LLC
Original FDA data
Every field from FDA enforcement report D-300-2013, exactly as published.
Show all FDA fields
- City
- San Diego
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 64933
- Address
- 6225 Progressive Dr
- Address (line 2)
- # 200
- Code information
- Lot #: 11649A0, Exp 12/13
- Postal code
- 92154-6643
- Report date
- May 1, 2013
- Product type
- Drugs
- Recall number
- D-300-2013
- Classification
- Class II
- Recalling firm
- OPMX, LLC
- Product quantity
- 7,610 bottles
- Termination date
- Aug 22, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Apr 12, 2013
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2013