Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
Reported: February 13, 2019 Initiated: December 7, 2018 #D-0427-2019
Product Description
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.
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
- 7020 units
- Distribution
- Nationwide within the United States
- Location
- Belleville, NJ
Frequently Asked Questions
What product was recalled? ▼
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14) and b) 6 oz tubes (NDC 53329-302-41), Medline Industries Inc., Manufactured for Medline Industries Inc., Mundelien, IL 60060.. Recalled by US Pharmaceuticals Inc.. Units affected: 7020 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-0427-2019.
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