Class II · Moderate risk
CVS Health Baby Eczema Moisturizing Cream
Microbial Contamination of Non Sterile Products; out of specification Total Plate Count
Eczema Skin Relief Lotion
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Microbial contamination of non-sterile product.
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
Eczema Skin Relief Lotion, 2% Colloidal Oatmeal Skin Protectant Lotion, NET WT 14 OZ (396 g), NDC 65365-266-01, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895.
Affected NDC
65365-0266-01
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Sigan Industries Inc.
- NDC code
- 65365-266-01
- Origin
- Canada
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0782-2020 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 Sigan Industries Inc.
All 2020 recallsOther microbial contamination recalls from 2020
All microbial contamination recalls
Class II · Moderate risk
Paroex (Chlorhexidine Gluconate)
cGMP Deviations; FDA inspection of manufacturing facility observed potential Burkholderia cepacia complex (BCC) contamination, inadequate cleaning, inadequate microbiological testing, and insanitary conditions
Class I · High risk
ManukaGuard Medical Grade Manuka Honey Allercleanse Nasal Spray
Microbial Contamination of Non-Sterile Products: Product confirmed to have yeast
Class I · High risk
Regenecare Ha
Microbial Contamination of Non-Sterile Drug Product. The product was found to be contaminated with the bacteria Burkholderia cepecia.
Class I · High risk
Chlorhexidine Gluconate Oral Rinse USP
Microbial contamination of non-sterile products: Repackaged product was recalled by manufacturer because it was contaminated with the bacteria Burkholderia lata.
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