Class I · High risk
Goldenseal POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Happy Ducts Compress
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
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
Happy Ducts Compress, 3 oz. plastic jar, www.wishgardenherbs.com, Boulder, CO. 80301. UPC 6 56490 20223 5
- Recalling firm
- Wishgarden Herbs, Incorporated
- Origin
- CO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0218-2021 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Wishgarden Herbs, Incorporated
All 2020 recalls
Class I · High risk
Cord Care POWDER
Microbial Contamination of a Non-Sterile Product: Product tested positive for Cronobacter Sakazakii.
Other 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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