VistaPharm, Inc.: 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. 66

Is my product affected?

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.

• Brand METHADONE HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

VistaPharm, Inc. is recalling methadone hydrochloride oral concentrate 10 mg/mL in two package sizes: 1 fluid ounce bottles (30 mL) and 1 liter bottles (1000 mL). The recall affects 127,193 bottles distributed nationwide. The company initiated this recall because purified water used to manufacture the products may have been contaminated with Burkholderia cepacia, a bacteria that does not meet current good manufacturing practice standards.

The recalled products include multiple lot numbers with various expiration dates ranging from January 2017 through December 2017. Affected lot numbers include 416600, 449100, 447500, 421800, 418600, 408700, 411900, 413800, 416500, 408500, 389800, 429900, 406300, 406100, 429700, 427300, 427100, and 425900. The recall notice does not specify what action consumers should take regarding recalled product they may have.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.

Details from the source

Reason for recall: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia. Distribution: Nationwide Quantity: 127,193 bottles Lot/code info: 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)

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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