Medline Remedy Essential Barrier Skin Protectant recall: Contamination
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.
Why was Medline Remedy Essential Barrier Skin Protectant recalled?
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # a) and b): 44G17, Exp. 05/2019
- Product
- 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.
- Recalling firm
- US Pharmaceuticals Inc.
- Quantity
- 7020 units
- Distribution
- Nationwide within the United States
- Recall date
- February 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)