Why it was recalled
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
Lot numbers, UPCs & expiration codes
Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0354-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jan 30, 2024
- FDA report date
- Mar 6, 2024
- Quantity
- 355,120 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Brassica Pharma Pvt Ltd
Original FDA data
Every field from FDA enforcement report D-0354-2024, exactly as published.
Show all FDA fields
- City
- Thane
- Status
- Ongoing
- Country
- India
- Event ID
- 93885
- Address
- Plot No. T-68, T 68 (Pt), T-63, Midc
- Address (line 2)
- Tarapur, Boisar
- Code information
- Lot #: A2G01, A2G02, Exp. Date Jun-24; A3F08, A3F09, Exp. Date May-25; A3J17, A3J18, Exp. Date Sep-25
- Report date
- Mar 6, 2024
- Product type
- Drugs
- Recall number
- D-0354-2024
- Classification
- Class II
- Recalling firm
- Brassica Pharma Pvt Ltd
- Product quantity
- 355,120 units
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Recall initiation date
- Jan 30, 2024
- Initial firm notification
- Letter
- Center classification date
- Feb 28, 2024