FDA (Drugs) recall action 81002
The FDA (Drugs) publishes a recall like this one as 79 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 79 pages.
Lack of Assurance of Sterility
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.
Pharm D Solutions is recalling Prostaglandin E1 80 mcg/mL Injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Phosphate Buffer Solution 0.05 m Aqueous Solution because the company cannot assure the product's sterility.
Pharm D Solutions is recalling specific lots of Calcium Gluconate 2.5% products due to a lack of assurance of sterility.
Pharm D Solutions is recalling 442 vials of HCG 6000 unit injectable nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 1,171 vials of HCG 10,000 unit/0.3 gm Mannitol Lyopholized nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Slenderella Compound Injectable because the product lacks assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling Acetylcysteine Injection 10 mg/5 mL because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling 264 vials of Oxytocin 30 unit in LR 500 mL IV bags nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling specific lots of Trimix Injectable because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling 409 vials of Sermorelin/GHRP-2 powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling HCG Reconstitued 6000 IU Injectable vials because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling specific lots of Prostaglandin E1 40 mcg/mL Injectable because the agency cannot assure the product is sterile.
Pharm D Solutions is recalling specific lots of Calcium Gluconate 10% Injectable because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling 521 syringes of Vigamox Ophthalmic Solution nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling 609 vials of Tri-Mix Injectable due to a lack of assurance of sterility. The product was distributed nationwide.
Pharm D Solutions is recalling Levocarnitine 170 mg/mL Injectable because the product lacks assurance of sterility. The recall covers 3,000 milliliters distributed nationwide.
Pharm D Solutions is recalling 4,000 mL of Glutathione 200 mg/mL Solution because the product lacks assurance of sterility.
Pharm D Solutions is recalling Glutamine 10 mg/mL Solution because the product lacks assurance of sterility. The recall covers specific lots distributed nationwide.
Pharm D Solutions is recalling 815 vials of Trimix injection because the company cannot guarantee the product is sterile.
Pharm D Solutions is recalling specific lots of Methylcobalamin 1 mg/mL injectable because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling QM-4A Quadmix Atropine 0.4 mg Aqueous Solution because there is a lack of assurance of sterility.
Pharm D Solutions is recalling 330 vials of Sermorelin/GHRP-2 Powder because the company cannot ensure the product is sterile.