ReBoost Nasal Spray
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Class I — High risk. Reasonable probability of serious harm or death.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
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.
ClearLife Allergy Nasal Spray, Extra Strength, 0.68 fl. oz. (20 mL) bottles, Distributed by: MediNatura, 10421 Research Rd., SE, Albuquerque, NM 87123, NDC 62795-4006-9, UPC 787647101887
Compare with the code on your package — it is the most precise check available.
Category: Allergy & Cold Medication
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Clearlife Extra Strength ONION, GALPHIMIA GLAUCA FLOWERING TOP, HISTAMINE DIHYDROCHLORIDE, LUFFA OPERCULATA FRUIT, SULFUR, AMBROSIA ARTEMISIIFOLIA WHOLE, EUPHRASIA STRICTA and SCHOENOCAULON OFFICINALE SEED NDC 62795-4006 |
ONION 4 [hp_X]/20mL; GALPHIMIA GLAUCA FLOWERING TOP 4 [hp_X]/20mL; HISTAMINE DIHYDROCHLORIDE 8 [hp_X]/20mL; LUFFA OPERCULATA FRUIT 3 [hp_X]/20mL; SULFUR 4 [hp_X]/20mL; AMBROSIA ARTEMISIIFOLIA WHOLE 4 [hp_X]/20mL; EUPHRASIA STRICTA 4 [hp_X]/20mL; SCHOENOCAULON OFFICINALE SEED 4 [hp_X]/20mL | Spray Nasal |
MediNatura Inc. | OTC |
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.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Microbial Contamination of Non-Sterile Products: The products have been found to contain yeast/mold and microbial contamination identified as Achromobacter.
Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
cGMP deviations: the firm released and distributed product which failed total aerobic microbial count testing.
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