Brassica Pharma Pvt Ltd: Drug Recall

Recall #D-0354-2024 · 01/30/2024

Class II: Risk

Recall Details

Recall Number
D-0354-2024
Classification
Class II
Product Type
Drug
Recalling Firm
Brassica Pharma Pvt Ltd
Status
Ongoing
Date Initiated
01/30/2024
Location
Thane, India
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
355,120 units

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

Distribution Pattern

Nationwide within the United States

Other Recalls by Brassica Pharma Pvt Ltd

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Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.