Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Gaia Kratom
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
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
Gaia Kratom (mitragyna speciosa) powder, Red MD, 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com
- Recalling firm
- Gaia Ethnobotanical LLC
- Origin
- NV, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1010-2018 · 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 Gaia Ethnobotanical LLC
All 2018 recalls
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Class I · High risk
Gaia Kratom
Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination
Other microbial contamination recalls from 2018
All microbial contamination recalls
Class II · Moderate risk
Medline Remedy Essential Barrier Skin Protectant Ointment
GMP Deviations: Out of specification results for Total Aerobic Microbial count in excipient purified water sample
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
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