Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Severe Congestion Nasal Spray (Oxymetazoline Hydrochloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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
Severe Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10
Affected NDC
41163-0343-10
Compare with the code on your package — it is the most precise check available.
Drug: Menthol Category: Allergy & Cold Medication
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 |
|---|---|---|---|---|
| Equaline Nasal Oxymetazoline hydrochloride NDC 41163-0343 |
.05 g/100mL | Spray Nasal |
United Natural Foods, Inc. dba UNFI | OTC |
- Recalling firm
- Perrigo Company PLC
- NDC code
- 41163-343-10
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0610-2022 · 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.
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Other recalls by Perrigo Company PLC
All 2021 recalls
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Maximum Strength Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
Sinus Severe
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
No Drip Nasal Spray
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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