← FDA ENFORCEMENT
D-0351-2024Class II

Brassica Pharma Pvt Ltd

Recalling firm
Brassica Pharma Pvt Ltd
Product type
Drug
Status
Ongoing
Report date
2024-03-06
Distribution
Nationwide within the United States
Product quantity
315,842 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Equate Lubricant Eye Ointment (Mineral Oil 42.5%, White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by Walmart Inc., Bentonville, AR 72716, NDC 79903-026-35, UPC 681131395298

Code / lot info

Lot #: A2E01, Exp. Date Apr-24; A2L05, Exp. Date Nov-24, A3B01, Exp. Date Jan-25; A3C01, Exp. Date Feb-25

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Data: U.S. FDA openFDA enforcement API. 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.