Drug Enforcement D-0545-2024

Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.

Status

Completed

Classification

Class II

Report Date

June 19, 2024

Termination Date

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Product Information

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,
Product quantity
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.
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide within the United States

Location & Firm

Recalling firm
Winder Laboratories, LLC
Address
716 Patrick Industrial Ln, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0545-2024
Event ID
94727
Recall initiation date
May 28, 2024
Center classification date
June 7, 2024
Code info
Lot#: 1142404 Exp. Date 02/27/2027
More code info
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