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
Reported: March 6, 2024 Initiated: January 30, 2024 #D-0354-2024
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
Reason for Recall
Lack of Assurance of Sterility
Details
- Recalling Firm
- Brassica Pharma Pvt Ltd
- Units Affected
- 355,120 units
- Distribution
- Nationwide within the United States
- Location
- Thane
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Brassica Pharma Pvt Ltd. Units affected: 355,120 units.
Why was this product recalled? ▼
Lack of Assurance of Sterility
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 6, 2024. Severity: Moderate. Recall number: D-0354-2024.
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