Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
Reported: August 21, 2019 Initiated: July 11, 2019 #D-1735-2019
Product Description
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22
Reason for Recall
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Details
- Recalling Firm
- US Pharmaceuticals Inc.
- Units Affected
- 830 tubes
- Distribution
- Distributed Nationwide in the USA
- Location
- Belleville, NJ
Frequently Asked Questions
What product was recalled? ▼
Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22. Recalled by US Pharmaceuticals Inc.. Units affected: 830 tubes.
Why was this product recalled? ▼
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 21, 2019. Severity: Moderate. Recall number: D-1735-2019.
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