Drug Enforcement D-0093-2024

Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.

Status

Terminated

Classification

Class III

Report Date

November 15, 2023

Termination Date

March 21, 2025

Product Information

Product description
Mycophenolate Mofetil for Oral Suspension, USP, 200 mg/mL, Rx Only, bottle, Manufactured for: VistaPharm, Inc., Largo, FL 33771, USA, NDC#66689-307-08.
Product quantity
11,633 bottles
Reason for recall
Defective Container: The adaptor does not fit into the neck of the bottle after reconstitution with water.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide and Saudi Arabia

Location & Firm

Recalling firm
VistaPharm LLC
Address
7265 Ulmerton Rd

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

Codes & Dates

Recall number
D-0093-2024
Event ID
93322
Recall initiation date
October 26, 2023
Center classification date
November 8, 2023
Code info
Lot #: M23400A, M23401A, M23402A, Exp Date. 04/30/2025; M23591A, M23592A, Exp Date. 06/30/2025.
More code info
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