Status
Ongoing
Drug Enforcement D-0354-2024
Lack of Assurance of Sterility
Classification
Class II
Report Date
March 6, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 355,120 units
- Reason for recall
- Lack of Assurance of Sterility
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide within the United States
Location & Firm
- Recalling firm
- Brassica Pharma Pvt Ltd
- Address
-
Plot No. T-68, T 68 (Pt), T-63, Midc, Tarapur, Boisar
India - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0354-2024
- Event ID
- 93885
- Recall initiation date
- January 30, 2024
- Center classification date
- February 28, 2024
- Code info
- Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
- More code info
- —