Drug Enforcement D-0176-2025

LABELING: LABEL MIX-UP

Status

Ongoing

Classification

Class III

Report Date

January 8, 2025

Termination Date

—

Product Information

Product description
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Product quantity
0
Reason for recall
LABELING: LABEL MIX-UP
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
AvKARE
Address
615 N 1st St

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

Codes & Dates

Recall number
D-0176-2025
Event ID
96032
Recall initiation date
December 18, 2024
Center classification date
January 2, 2025
Code info
Lot #: 0160, Exp. Date April 26 2026
More code info
—