FDA Recall D-0353-2024

Brassica Pharma Pvt Ltd

Class II Ongoing 835 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

Lot / code: 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

Quantity: 159,334 units

Reason for recall

Lack of Assurance of Sterility

Recall record

Recall number: D-0353-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2024-01-30
Classified by FDA Center: 2024-02-28
FDA published: 2024-03-06
Recalling firm: Brassica Pharma Pvt Ltd

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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