Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
X-Jow (menthol USP)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: products may be contaminated with bacteria.
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
X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC 850547 00502 6) and b) 8 oz. (226g) bottles (UPC 8 50547 00503 3, Distributed by Herb-X Solutions, Inc., 3838 West Burbank Blvd., Burbank CA 91505.
Drug: Menthol
- Recalling firm
- Shadow Holdings DBA Bocchi Labs
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0858-2018 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Menthol recalls
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Class II · Moderate risk
Rohto Cooling Eye Drops Cool Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Dry Aid
Lack of Assurance of Sterility
Class II · Moderate risk
Rohto Cooling Eye Drops Digi Eye
Lack of Assurance of Sterility
Other recalls by Shadow Holdings DBA Bocchi Labs
All 2018 recalls
Class II · Moderate risk
Acne Shave 3 Step Shaving System
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave
CGMP Deviations: products may be contaminated with bacteria.
Class II · Moderate risk
Acne Shave Post-Shave Moisturizer
CGMP Deviations: products may be contaminated with bacteria.
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