allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-
Summary
The FDA issued a Class II for allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-coun by L. Perrigo Company. Reason: Failed Impurities/Degradation Specifications.
Details
Source
Drug Recall
External ID
D-0909-2023
Action Date
2023-07-19
Status
Terminated
Category
drug
Product Description
allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count cartons (NDC 56062-847-95), Distributed by: Publix Super Markets, Inc., 3300 Publix Corporate Parkway, Lakeland, FL 33811.
Lot/Code Info: Lot #: a) 2CR0652, 2DR0464, 2DR0465,Exp. Date 12/23; 2ER0285, Exp. Date 01/24. b) 2DR0466, Exp. Date 12/23; 2ER0412, Exp. Date 01/24; 2GR0330, Exp. Date 04/24
Quantity Affected: 32,904 cartons
Reason for Recall
Failed Impurities/Degradation Specifications
Distribution
Nationwide within the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-02-09
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 59 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
L. Perrigo Company has 13 FDA actions in our database, including 13 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 (L. Perrigo Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does L. Perrigo Company have FDA actions?
L. Perrigo Company has 13 FDA actions in our database, including 13 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0909-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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