Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Manufacturer: Ricola Ltd., 4242 Laufen, Switzerland; Distributed by: Ricola USA Inc., 6 Campus Drive, 2nd Floor South, Parsippany, NJ 07054. NDC: 54305-507-10
Compare with the code on your package — it is the most precise check available.
Drug: Menthol
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 |
|---|---|---|---|---|
| Natural Cherry Honey Herb Throat Drops Menthol NDC 54305-0507 |
1.8 mg/1 | Lozenge Oral |
Ricola Ag | OTC |
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.
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
Lack of Assurance of Sterility
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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