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 Diltiazem HCl products because they may contain latex but lack proper labeling.
Advanced Pharma Inc. is recalling Ropi/ Epi/ Clon PeriCapsular injection because the product may contain latex and lacks appropriate labeling.
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 all Oxytocin products due to a labeling issue regarding potential synthetic or natural latex content.
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 Cefazolin because the product may contain latex but lacks appropriate labeling.
Advanced Pharma Inc. is recalling Dexamethasone Sodium Phosphate because the product may contain latex but lacks proper labeling.
Advanced Pharma Inc. is recalling Standard Starter TPN products because they may contain synthetic or natural latex without proper labeling.
Advanced Pharma Inc. is recalling all lots of Phenylephrine HCl because the product may contain latex but lacks appropriate labeling.
Advanced Pharma Inc. is recalling all lots of Sufentanil Citrate because the product may contain latex, which is not currently disclosed on the label.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Bumetanide because the product labeling fails to disclose that it may contain synthetic or natural latex.
Advanced Pharma Inc. is recalling all lots of Famotidine HCl because the product may contain latex but lacks proper labeling.
Advanced Pharma Inc. is recalling TPN Neonatal products because they may contain latex but lack proper labeling.
Advanced Pharma Inc. is recalling Magnesium Sulfate products due to potential latex content not clearly labeled.
Advanced Pharma Inc. is recalling all lots of Nicardipine HCl because the product may contain latex but lacks appropriate labeling.
Advanced Pharma Inc. is recalling all Amiodarone products due to a labeling issue regarding potential synthetic or natural latex content.
Advanced Pharma Inc. is recalling Fentanyl Citrate with Ropivacaine HCl because the product may contain latex and lacks appropriate labeling.
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 Epinephrine HCl products because they may contain latex but lack appropriate labeling.
Advanced Pharma Inc. is recalling all Gentamicin Sulfate products due to a labeling error regarding potential latex content.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Ondansetron HCl because the product labeling may not adequately disclose the presence of synthetic or natural latex.
Advanced Pharma Inc. is recalling all strengths and dosage forms of Neostigmine Methylsulfate because the product may contain latex without proper labeling.
Advanced Pharma Inc. is recalling Labetalol HCl products because labels may not properly disclose the presence of synthetic or natural latex.
Advanced Pharma Inc. is recalling all lots of Penicillin G Potassium because the product may contain latex but lacks appropriate labeling.
Advanced Pharma Inc. is recalling Bupivacaine HCl in 0.9% Sodium Chloride because the product may contain synthetic or natural latex, which is not properly labeled.