Class II · Moderate risk
Healthful Naturals Leg Cramp Support Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Native Remedies VaricoGo Oral Spray
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Microbial Contamination of Non-Sterile Products
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
Native Remedies VaricoGo Oral Spray, 2 fl oz (59 mL) per bottle, Distributed by: Silver Star Brands, Oshkosh, WI 54906. NDC 68703-105-59
Affected NDC
68703-0105-59
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- Silver Star Brands
- NDC code
- 68703-105-59
- Origin
- WI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0253-2019 · 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 Silver Star Brands
All 2018 recalls
Class II · Moderate risk
Healthful Naturals DizziFree Oral Spray
CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
Class I · High risk
Native Remedies EyeClear Pro Oral Spray
Microbial Contamination of Non-Sterile Product
Class I · High risk
Native Remedies HypoSlim Oral Spray
Microbial Contamination of Non-Sterile Products
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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