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Class II: temporary or reversible health riskTerminated

Perrigo Maximum Strength No Drip Nasal Spray Recall

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0

Perrigo Company PLC · Allegan, MI

Risk level
Class II
Reported by FDA
Mar 2, 2022
Recall ID
D-0624-2022
Check your lot numberHow we source this data

Summary

Perrigo recalled Maximum Strength No Drip Nasal Spray starting Oct 26, 2021. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0624-2022 on Mar 2, 2022. Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier. Status: Terminated.

Why it was recalled

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

Product description

Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10

Lot numbers, UPCs & expiration codes

Batch: 1BK0826, Exp 12/31/2022

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0624-2022
Classification
Class II
Status
Terminated
Recall initiated
Oct 26, 2021
FDA report date
Mar 2, 2022
Quantity
36,864 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Perrigo Company PLC

Original FDA data

Every field from FDA enforcement report D-0624-2022, exactly as published.

Show all FDA fields
City
Allegan
State
MI
Status
Terminated
Country
United States
Event ID
88905
Address
515 Eastern Ave
Code information
Batch: 1BK0826, Exp 12/31/2022
Postal code
49010-9070
Report date
Mar 2, 2022
Product type
Drugs
Recall number
D-0624-2022
Classification
Class II
Recalling firm
Perrigo Company PLC
Product quantity
36,864 bottles
Termination date
Sep 29, 2023
Reason for recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Voluntary / mandated
Voluntary: Firm initiated
Product description
Maximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
Distribution pattern
Nationwide in the USA
Recall initiation date
Oct 26, 2021
Initial firm notification
Letter
Center classification date
Feb 23, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0624-2022, published Mar 2, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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