FDA (Drugs) recall action 72177
The FDA (Drugs) publishes a recall like this one as 22 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 22 pages.
Stability data does not support expiry.
Subpotent drug.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Pharmakon Pharmaceuticals is recalling 5,000 syringes of Midazolam 1 mg/mL because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.
Pharmakon Pharmaceuticals is recalling 600 syringes of Ketamine 100 mg/mL because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 378 units of Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers lots expiring up to November 17, 2015.
Pharmakon Pharmaceuticals is recalling 8,000 units of Hydromorphone HCl 1 mg/mL syringes nationwide because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 1,150 syringes of Epinephrine (PF) 10 mcg/mL because the drug was found to be subpotent. The recall is voluntary and nationwide.
Pharmakon Pharmaceuticals is recalling Phenylephrine injectable syringes because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 665 syringes of Midazolam (PF) because stability data does not support the expiration dates. The recall is nationwide.
Pharmakon Pharmaceuticals is recalling 475 syringes of Morphine Sulfate (PF) 0.5 mg/mL because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 250 syringes of Ketamine 50 mg/mL because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 525 syringes of Morphine Sulfate because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall covers all lots expiring through November 17, 2015.
Pharmakon Pharmaceuticals is recalling Lidocaine HCI 2% injectable syringes because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling Ephedrine Sulfate 5 mg/mL injectable syringes because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. All lots expiring up to 11/17/2015 are affected.
Pharmakon Pharmaceuticals is recalling 4,100 units of Ondansetron 2 mg/mL injectable syringes because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 5,875 units of Rocuronium 10 mg/mL syringes because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling 210 syringes of Midazolam (PF) 0.5 mg/mL because the drug is subpotent. The recall is voluntary and nationwide.
Pharmakon Pharmaceuticals is recalling 2,750 syringes of Succinylcholine 20 mg/mL because stability data does not support the expiration dates.
Pharmakon Pharmaceuticals is recalling Fentanyl Citrate syringes because stability data does not support the expiration dates. The recall covers 7,100 units distributed nationwide.
Pharmakon Pharmaceuticals is recalling Provocholine Pre-diluted Set II because stability data does not support the expiration dates. The recall affects lots expiring through November 17, 2015.
Pharmakon Pharmaceuticals is recalling 1,530 syringes of Glycopyrrolate 0.2 mg/mL because stability data does not support the expiration dates.