Drug Enforcement D-0540-2023

CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.

Status

Completed

Classification

Class II

Report Date

May 3, 2023

Termination Date

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Product Information

Product description
Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial, Rx only, For Intravenous Infusion Only, Mfd. for Methapharm, Inc. Coral Springs, FL, 33065, NDC 67850-150-10 (carton), NDC 67850-150-00 (vial).
Product quantity
5377 cartons
Reason for recall
CGMP Deviations; The impacted product and lot number was inadvertently placed into saleable inventory, which does not comply with approved procedures.
Recall initiation reason
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Initial firm notification
Letter
Distribution pattern
Nationwide in the USA

Location & Firm

Recalling firm
Methapharm Inc
Address
11772 W Sample Rd Ste 101, N/A

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

Codes & Dates

Recall number
D-0540-2023
Event ID
92113
Recall initiation date
April 7, 2023
Center classification date
April 21, 2023
Code info
Lots: 220801; 220802; 220803 Exp. July 2024
More code info
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