Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patr
Summary
The FDA issued a Class II for Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufacture by Winder Laboratories, LLC. Reason: Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg..
Details
Source
Drug Recall
External ID
D-0545-2024
Action Date
2024-06-19
Status
Completed
Category
drug
Product Description
Phenazopyridine HCl Tablets USP, 100 mg, 100-count bottles, Rx Only, Manufactured by: Winder Laboratories, LLC. 716 Patrick Industrial Lane, Winder, GA 30680, NDC 75826-114-10,
Lot/Code Info: Lot#: 1142404 Exp. Date 02/27/2027
Quantity Affected: 473 cases (5676 Bottles)
Reason for Recall
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Distribution
Nationwide within the United States
Type: Voluntary: Firm initiated
Recall Initiated: 2024-05-28
Company
Winder, GA
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 49 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 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 (Winder Laboratories, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Winder Laboratories, LLC have FDA actions?
Winder Laboratories, LLC has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0545-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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