FDAFDA · Food and drugs·Recall number D-1416-2012
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.
Published July 18, 2012 · Recall initiated: May 30, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Impurities/Degradation Products: exceeded specification at 3 month stability testing
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- Lot #'s a) 251400, Exp 07/13; b) 251500 Exp 07/13.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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