Drug recall D-0467-2017

Class II Terminated reported Feb 8, 2017

Product

Methadone Hydrochloride Oral Concentrate, USP 5 mg/5 mL C-II, 500 mL, 6 bottles per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-711-16.

Reason for recall

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

Lots and codes

Lot No. 388700 (Exp. 01/17)

Recall details

Recalling firm
VistaPharm, Inc., Largo, FL
Quantity
3,354 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
January 18, 2017
Terminated
August 26, 2021

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