FDA (Drugs) recall action 76561
The FDA (Drugs) publishes a recall like this one as 60 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 60 pages.
Labeling: Not Elsewhere Classified: Products may contain synthetic latex and/or natural latex.
The agency’s own wording, quoted from the enforcement report.
Advanced Pharma Inc. is recalling all lots of Hydromorphone HCl because the product labeling does not properly disclose that it may contain synthetic or natural latex.
Advanced Pharma Inc. is recalling all lots of Dexmedetomidine HCl because the product may contain synthetic or natural latex, which is not currently labeled.
Advanced Pharma Inc. is recalling Betamethasone Sodium Phosphate & Betamethasone Acetate products because they may contain latex but lack appropriate labeling.
Advanced Pharma Inc. is recalling all strengths and forms of Rocuronium Bromide because the product may contain latex without proper labeling.
Advanced Pharma Inc. is recalling Sodium Phosphate products because they may contain latex but lack proper labeling. The recall covers all strengths and dosage forms distributed nationwide.
Advanced Pharma Inc. is recalling Early TPN (Neonatal) products nationwide due to a labeling error regarding potential latex content.
Advanced Pharma Inc. is recalling all lots of Fentanyl Citrate because the product labeling does not indicate that it may contain synthetic or natural latex.
Advanced Pharma Inc. is recalling NICU Starter TPN products because they may contain synthetic or natural latex without proper labeling.
Advanced Pharma Inc. is recalling Early Baby TPN (Neonatal) because the product may contain synthetic or natural latex, which is not currently labeled.
Advanced Pharma Inc. is recalling all lots of Ephedrine Sulfate because the product may contain latex but lacks proper labeling.