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D-0353-2024Class II

Brassica Pharma Pvt Ltd

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Brassica Pharma Pvt Ltd
Product type
Drug
Status
Ongoing
Report date
2024-03-06
Distribution
Nationwide within the United States
Product quantity
159,334 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

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

Code / lot 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

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →