Drug Enforcement D-0353-2024

Lack of Assurance of Sterility

Status

Ongoing

Classification

Class II

Report Date

March 6, 2024

Termination Date

Product Information

Product description
CVS Health Lubricant Eye Ointment (Mineral oil 31.9% Emollient, White petrolatum 57.7% Emollient), Packaged in in 3.5 gram tubes, Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 76168-707-35, UPC 050428634141
Product quantity
159,334 units
Reason for recall
Lack of Assurance of Sterility
Recall initiation reason
Initial firm notification
Letter
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Brassica Pharma Pvt Ltd
Address
Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar

India
Voluntary / Mandated
Voluntary: Firm initiated
Status date

Codes & Dates

Recall number
D-0353-2024
Event ID
93885
Recall initiation date
January 30, 2024
Center classification date
February 28, 2024
Code info
Lot #: A2F03, Exp. Date May-24; A2I02, Exp. Date Aug-24; A2L02, Exp. Date Nov-24; A3C04, Exp. Date Feb-25; A3H04, Exp. Date Jul-25
More code info