Drug Enforcement D-0298-2024

Non-Sterility

Status

Ongoing

Classification

Class I

Report Date

February 14, 2024

Termination Date

Product Information

Product description
CVS Health brand, Lubricant Gel Drops (Carboxymethylcellulose Sodium 1%) packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-704-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-704-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895.
Product quantity
150,720 bottles
Reason for recall
Non-Sterility
Recall initiation reason
Initial firm notification
Press Release
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Kilitch Healthcare India Limited
Address
R - 904 905 T T C Industrial Road

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0298-2024
Event ID
93357
Recall initiation date
November 13, 2023
Center classification date
February 5, 2024
Code info
All lots
More code info