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Opioid Detox Med Recalled


February 13, 2017

VistaPharm, Inc, is recalling 127,193 bottles of Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II, according to the US Food and Drug Administration (FDA) Enforcement Report for the week of February 8, 2017 (http://bit.ly/1WfaCbN).

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The ongoing, Class II, nationwide recall affects the following:

  • 1 fl. oz. (30 mL), 12 bottles per case (NDC 66689-695-30): Lot number 416600 (Exp. 09/17)
  • 1 liter (1000 mL), 4 bottles per case (NDC 66689-695-79): Lot numbers 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)

The recall was voluntarily initiated by VistaPharm on January 18, 2017, on account of Current Good Manufacturing Practice deviations. “Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia,” the FDA report states.

The company is also recalling 14,368 bottles of Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL; Lot No. 423000 [Exp. 10/17], 415100 [Exp. 08/17]) and 3354 bottles of Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL (Lot No. 388700 (Exp. 01/17) for the same reason.

Methadone hydrochloride is indicated for the detoxification and maintenance treatment of opioid addiction.--Meredith Edwards White

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