Class II · Moderate risk
Zicam
CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
Maximum Strength 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
Maximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
Affected NDC
41250-0989-10
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 |
|---|---|---|---|---|
| nasal oxymetazoline hydrochloride NDC 41250-0989 |
.05 g/100mL | Spray Nasal |
Meijer Distribution Inc | OTC |
- Recalling firm
- Perrigo Company PLC
- NDC code
- 41250-989-10
- Origin
- MI, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0629-2022 · 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
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CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Class II · Moderate risk
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CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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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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