Reported Feb 13, 2019 · Terminated
Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%) packaged in a) 2 oz tubes (NDC 53329-302-14)…
US Pharmaceuticals Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: US Pharmaceuticals Inc. · 681 Main St Ste 27 · Belleville, NJ · 07109-3471
Is this the product you have?
- 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.
- Lot codes and dates
- Lot #
- a) and b)
44G17Exp. 05/2019
- Amount recalled
- 7020 units
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
This product could cause temporary or reversible health problems — stop using it.
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