D-0506-2022 Class II Terminated

Recalled by Ultra Seal Corporation — New Paltz, NY

FDA drug recall D-0506-2022 was initiated by Ultra Seal Corporation on Jan 24, 2022 and is designated Class II. Reason for recall: cGMP deviations The recall status is terminated (terminated Oct 16, 2023). Affected quantity: 90,072 bottles.

Recall Details

Product Type
Drugs
Report Date
Feb 9, 2022
Initiation Date
Jan 24, 2022
Termination Date
Oct 16, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
90,072 bottles

Product Description

MidNite Natural sleep aid Chewable Tablets Cherry Flavor (melatonin 1.5mg), 30-count bottles, BGP Pharma ULC, Etobicoke, ON M8Z 2S6

Reason for Recall

cGMP deviations

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: 19C038C, Exp. Date 03/2022; 19G047C, Exp. Date 07/2022; 18L124C, Exp. Date 02/2022

Source

Dataset
openFDA drug recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for D-0506-2022
openFDA file date
Oct 26, 2026
Loaded by RegDataLab
Oct 27, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.