Drug Enforcement D-0056-2025

cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.

Status

Ongoing

Classification

Class II

Report Date

November 27, 2024

Termination Date

Product Information

Product description
Vitamin D3, 25 mcg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-104-01
Product quantity
7488 boxes
Reason for recall
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Safecor Health, LLC
Address
317 New Boston St, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0056-2025
Event ID
95659
Recall initiation date
November 11, 2024
Center classification date
November 19, 2024
Code info
Lot# 24A0052, exp. date 05/01/2026; 24A0057, exp. date 05/13/2026; 24A0066, exp. date 05/31/2026; 24A0067, exp. date 06/04/2026; 24A0068, exp. date 06/17/2026; 24A0069, exp. date 06/19/2026 24A0075, exp. date 07/08/2026 24A0078, exp. date 07/12/2026
More code info