Wells Pharma Of Houston Llc: Fentanyl Citrate Injectable Solution In 0.9% Sodium Chloride, 1000 Mcg/50ml (20 Mcg Per Ml), Well Pharma Of Houston
Wells Pharma of Houston LLC is recalling fentanyl citrate injectable solution (1000 mcg/50mL vials) distributed nationwide because the manufacturer did not follow required manufacturing standards (cGMP deviations). This is a Class II recall, meaning use of the product could cause serious health problems or death. The recall affects hospitals, clinics, and other healthcare facilities across all U.S. states that received this medication.
- Recalling firm
- Wells Pharma of Houston LLC
- Product
- fentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well pharma of Houston, NDC 73702-203-65.
- Reason
- cGMP deviations.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-04-01
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide.
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/ab8745cb-0d9a-4c58-848e-5eac1d21d8b0