FDAFDA · Food and drugs·Recall number D-0465-2017
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, a.) 1 fl. oz. (30 mL), 12 bottles per case (NDC No. 66689-695-30), b). 1 liter (1000 mL), 4 bottles per case, (NDC No. 66689-695-79), 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
- Brand
- METHADONE HYDROCHLORIDE
- Manufacturer
- VistaPharm, Inc.
- Distributor
- Nationwide
- Lot
- a). Lot No. 416600 (Exp. 09/17) b). Lot No.449100 , 447500 (Exp. 04/18), 421800 (Exp. 10/17), 418600 (Exp. 09/17), 408700 (Exp. 06/17), 411900 (Exp. 07/17), 413800 (Exp. 08/17), 416500 (Exp. 09/17), 408500 (Exp. 06/17), 389800 (Exp. 01/17), 429900 (Exp. 12/17), 406300, 406100 (Exp. 05/17), 429700 (Exp. 12/17), 427300, 427100, 425900 (11/17)
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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