Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Product description
Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
Lot numbers, UPCs & expiration codes
Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
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-0425-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 7, 2018
- FDA report date
- Feb 13, 2019
- Quantity
- 19752 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- US Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0425-2019, exactly as published.
Show all FDA fields
- City
- Belleville
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 81784
- Address
- 681 Main St Ste 27
- Code information
- Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
- Postal code
- 07109-3471
- Report date
- Feb 13, 2019
- Product type
- Drugs
- Recall number
- D-0425-2019
- Classification
- Class II
- Recalling firm
- US Pharmaceuticals Inc.
- Product quantity
- 19752 units
- Termination date
- Nov 6, 2023
- Reason for recall
- GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%),3.5 oz tubes, Manufactured in USA for: Medline Industries, Inc., Mundelein, IL 60060 USA NDC 53329-303-22
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 7, 2018
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2019