Why it was recalled
Impurities/Degradation Products: exceeded specification at 3 month stability testing
Product description
Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
Lot numbers, UPCs & expiration codes
Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
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-1416-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- May 30, 2012
- FDA report date
- Jul 18, 2012
- Quantity
- a) 949 Cases, b) 188 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1416-2012, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 62405
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
- Postal code
- 33771-4809
- Report date
- Jul 18, 2012
- Product type
- Drugs
- Recall number
- D-1416-2012
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- a) 949 Cases, b) 188 bottles
- Termination date
- May 22, 2013
- Reason for recall
- Impurities/Degradation Products: exceeded specification at 3 month stability testing
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydrocodone Bitartrate & Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL, a) 15 mL Unit Dose Cups (50 unit dose cups per case), b) 473 mL Bottles, C III, Rx Only, Warning May be habit forming, Manufactured by VistaPharm, Largo, FL 33771, NDC a) 66689-023-50, b) NDC 66689-023-16.
- Distribution pattern
- Nationwide
- Recall initiation date
- May 30, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 12, 2012