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
Reported: February 13, 2019 Initiated: December 7, 2018 #D-0425-2019
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
Reason for Recall
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Details
- Recalling Firm
- US Pharmaceuticals Inc.
- Units Affected
- 19752 units
- Distribution
- Nationwide within the United States
- Location
- Belleville, NJ
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by US Pharmaceuticals Inc.. Units affected: 19752 units.
Why was this product recalled? ▼
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 13, 2019. Severity: Moderate. Recall number: D-0425-2019.
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