← FDA ENFORCEMENT
D-0354-2024Class 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
355,120 units
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Lack of Assurance of Sterility

Product description

Lubricant PM Ointment (Mineral Oil 42.5% and White Petrolatum 57.3%), Packaged in 3.5 gram tubes, Distributed by: AACE Pharmaceuticals, Inc., Fairfield, NJ 07004, NDC 71406-124-35, UPC 371406124356

Code / lot info

Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-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.