PHENAZOPYRIDINE HYDROCHLORIDE Recall D-0545-2024
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,
PHENAZOPYRIDINE HYDROCHLORIDE Recall D-0545-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0545-2024 |
| Event ID | 94727 |
| Brand | PHENAZOPYRIDINE HYDROCHLORIDE |
| Generic Name | PHENAZOPYRIDINE HYDROCHLORIDE |
| Manufacturer | PHENAZOPYRIDINE HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | PHENAZOPYRIDINE HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | Nationwide within the United States |
| Quantity | 473 cases (5676 Bottles) |
| Recall Reason | Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg. |
| Drug Classification | Class II |
| Drug Code Info | 20240619 |
| Product NDC | 75826-114 75826-115 |
| Drug UPC | 0375826115109 0375826114102 |
| Recall Initiation Date | 20240528 |
| Report Date | 20240619 |
| Classification Date | 20240607 |
| Address | 716 Patrick Industrial LnN/A Winder, GA 30680-8333 United States |
| Recalling Firm | Winder Laboratories, LLC |
| Initial Notification | |
| Unique Ingredient Identifier | 0EWG668W17 |
| Structured Product Labeling (SPL ID) | e0537551-5536-d23c-e053-2995a90af439 |
| Structured Product Labeling (SPL Set ID) | 0a190e86-4074-4822-888e-4952281712ea |
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