Recalls / Class II
Class IID-0545-2024
Product
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,
- Brand name
- Phenazopyridine Hydrochloride
- Generic name
- Phenazopyridine Hydrochloride
- Active ingredient
- Phenazopyridine Hydrochloride
- Route
- Oral
- NDCs
- 75826-114, 75826-115
- Affected lot / code info
- Lot#: 1142404 Exp. Date 02/27/2027
Why it was recalled
Product Mix Up. A bottle of Phenazopyridine HCl tablets USP 100 mg contained Phenobarbital tablets 16.2 mg.
Recalling firm
- Firm
- Winder Laboratories, LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 716 Patrick Industrial Ln, N/A, Winder, Georgia 30680-8333
Distribution
- Quantity
- 473 cases (5676 Bottles)
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-05-28
- FDA classified
- 2024-06-07
- Posted by FDA
- 2024-06-19
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0545-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.