Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
aulief (Organic Camphor 3.00% Organic Menthol 5.00%) (Menthol and Camohor)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, packaged as a) 3.2 oz (90.7g) tube UPC 6 87806 30003 1 NDC 76305-302-01 ; b) 7.0 oz (198.5g) tube, UPC 6 87806 30007 9, NDC 76305-302-02; c) 16 oz (453.6g)Bottle w/ Pump, UPC 6 87806 30016 1, NDC 76305-302-03; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
Affected NDCs
76305-0302-01
76305-0302-02
76305-0302-03
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
Product details
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 |
|---|---|---|---|---|
| Aulief Topical Pain Reliever Menthol and Camohor NDC 76305-0302 |
CAMPHOR (NATURAL) 30 mg/g; MENTHOL 50 mg/g | Cream Topical |
China-Gel, LLC | OTC |
- Recalling firm
- China Gel Inc
- NDC code
- 76305-302-01
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0790-2021 · 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.
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Other recalls by China Gel Inc
All 2021 recalls
Class II · Moderate risk
China-Gel White
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Class II · Moderate risk
CHINA_GEL (Camphor 3.00%, Menthol 5.00%)
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
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