FDAFDA · Food and drugs·Recall number D-0458-2017
Hydrocodone Bitartrate and Acetaminophen Oral Solution, 7.5 mg/325 mg per 15 mL C-II, a) 4 fl.oz .(120 mL), 12 bottles per case (NDC 66689-023-04), b) 16 fl.oz. (473 mL), 12 bottles per case (NDC 66689-023-16), c) 50 unit dose cups of 15 mL per case, (NDC No. 66689-023-50), Rx only, Manufactured by VistaPharm, Largo, FL 33771
Published February 8, 2017 · Recall initiated: January 18, 2017
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
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- a). Lot No. 419000 (Exp. 03/17) b.) Lot No. 419800 (Exp. 03/17), 429100 (Exp. 06/17) c). Lot No. 418200 (Exp. 03/17), 430100 (Exp. 06/17), 423800 (Exp. 04/17), 413100 (Exp. 02/17), 410700 (Exp. 01/17)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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