Recalls / Class II
Class IID-0425-2019
Product
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
- Affected lot / code info
- Lot #: 50G17, Exp. 5/2019; 76J17, Exp. 7/2019
Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Recalling firm
- Firm
- US Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 681 Main St Ste 27, Belleville, New Jersey 07109-3471
Distribution
- Quantity
- 19752 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2018-12-07
- FDA classified
- 2019-02-04
- Posted by FDA
- 2019-02-13
- Terminated
- 2023-11-06
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0425-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.