Methadone Hydrochloride Concentrate
FDA Recall NDC 66689-694
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Methadone Hydrochloride (NDC 66689-694). A significant event, classified as Class II, was initiated on Jan 18, 2017 by Vistapharm, Llc. The reported reason for this action was: "CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Jan 18, 2017
Feb 08, 2017
14,368 bottles
Recall Profile & Regulatory Data
Event ID
75650
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VistaPharm, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 26, 2021
Product Description
Methadone Hydrochloride Oral Concentrate, USP 10 mg/mL C-II (Sugar Free), 1 liter (1000 mL), 4 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-695-79.
Batch or Lot Expiration Information
Lot# Lot No. 423000 (Exp. 10/17), 415100 (Exp. 08/17)
Affected Packages Involved in this Recall
66689-694-30Product
66689-694-79Product
66689-694-88Product
66689-695-79Product
Class II Terminated
CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Jan 18, 2017
Feb 08, 2017
127,193 bottles
Recall Profile & Regulatory Data
Event ID
75650
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
VistaPharm, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Aug 26, 2021
Product Description
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.
Batch or Lot Expiration Information
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)
Affected Packages Involved in this Recall
66689-694-30Product
66689-694-79Product
66689-694-88Product
66689-695-79Product
66689-695-30Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
