No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU IN
Summary
The FDA issued a Class II for No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) by Perrigo Company PLC. Reason: CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier..
Details
Source
Drug Recall
External ID
D-0623-2022
Action Date
2022-03-02
Status
Terminated
Category
drug
Product Description
No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
Lot/Code Info: Batch: 1BK0964, Exp 01/31/2023
Quantity Affected: 1,560 bottles
Reason for Recall
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-10-26
Company
Allegan, MI
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 98 drug recalls issued in the same week, part of 272 drug-related FDA actions this month.
Perrigo Company PLC has 81 FDA actions in our database, including 81 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Perrigo Company PLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Perrigo Company PLC have FDA actions?
Perrigo Company PLC has 81 FDA actions in our database, including 81 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0623-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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