Class II · Moderate risk
CVS Health Hydrating Healing Ointment
Lack Of CGMP:s Low weight fill tubes were identified in one lot of CVS Healing Ointment.
Medline Remedy Essential Barrier Skin Protectant Ointment
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What 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.
Affected NDCs
53329-0302-14
53329-0302-41
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- US Pharmaceuticals Inc.
- NDC code
- 53329-302-14
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0427-2019 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by US Pharmaceuticals Inc.
All 2018 recalls
Class II · Moderate risk
CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Wonder Freeze Pain Releiving Gel with ILEX
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Class II · Moderate risk
Kool Comfort Cooling Pain Relief
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Other microbial contamination recalls from 2018
All microbial contamination recalls
Class II · Moderate risk
Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Soothe & Cool Protect Moisture Guard Skin Protectant
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
Class II · Moderate risk
Germ Bloc Health Hand Sanitizer Foam
Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product
Class II · Moderate risk
Alcohol Free Foaming Hand Sanitizer
CGMP Deviations: Product was released to market prior to microbiological testing.
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