Drug Enforcement D-0018-2023

cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

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Status

Terminated

Classification

Class II

Report Date

November 2, 2022

Termination Date

April 30, 2024

Product Information

Product description
Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01
Product quantity
1980 cups
Reason for recall
cGMP Deviations: Out of specification for assay of one of the preservative ingredients.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA Nationwide

Location & Firm

Recalling firm
VistaPharm, Inc.
Address
7265 Ulmerton Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0018-2023
Event ID
90943
Recall initiation date
September 30, 2022
Center classification date
October 21, 2022
Code info
Lot#: 832400, Exp 08/2023
More code info
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