Why it was recalled
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Product description
CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
Lot numbers, UPCs & expiration codes
Lot # 41C19 Exp 3/2021
Where it was sold
Distributed in RI
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-0113-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 19, 2020
- FDA report date
- Dec 9, 2020
- Quantity
- 3312 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0113-2021, exactly as published.
Show all FDA fields
- City
- Belleville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86868
- Address
- 681 Main St Ste 27
- Code information
- Lot # 41C19 Exp 3/2021
- Postal code
- 07109-3471
- Report date
- Dec 9, 2020
- Product type
- Drugs
- Recall number
- D-0113-2021
- Classification
- Class II
- Recalling firm
- US Pharmaceuticals Inc.
- Product quantity
- 3312 units
- Termination date
- Feb 1, 2022
- Reason for recall
- Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- CVS Health Hydrating Healing Ointment (Petrolatum 41%), Net Wt 3 OZ (85g), Distributed by CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895 UPC 0 50428 53642 1
- Distribution pattern
- Distributed in RI
- Recall initiation date
- Nov 19, 2020
- Initial firm notification
- Letter
- Center classification date
- Dec 1, 2020