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 179 vials of Sermorelin/Ipamorelin powder because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 70 bottles of Epi-Shugarcaine Kit Solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling 517 syringes of Reck Injection because the product lacks assurance of sterility. The recall covers lots distributed nationwide.
Pharm D Solutions is recalling 2,219 vials of HCG Lyophilized 5000 IU Injectable because the product lacks assurance of sterility.
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 521 syringes of Vigamox Ophthalmic Solution nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Arginine Injections 100 mcg/mL due to a lack of assurance of sterility. The affected lots were distributed nationwide.
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 945 syringes of Epinephrine 1 mg/1 mL injectable solution nationwide due to a lack of assurance of sterility.
Pharm D Solutions is recalling Trimix T-101 injection because the product may lack 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 Trimix BM3 Papaverine 30 mg/Phentolamine 1 mg Injectable because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling 29 vials of Bi-Mix (Papaverine/Phentolamine) injectable and powder nationwide due to a lack of assurance of sterility.
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 Slenderella Compound Injectable because the product lacks assurance of sterility.
Pharm D Solutions is recalling specific lots of Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable because of 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 Trimix T-106 aqueous solution because the company cannot ensure the product is sterile.
Pharm D Solutions is recalling specific lots of Trimix QM10 Injectable because the company cannot ensure the product is sterile.
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 Trimix T 101 Injectable due to a lack of assurance of sterility. The recall covers a specific lot distributed nationwide.
Pharm D Solutions is recalling Ascorbic Acid 500 mg/mL Solution due to a lack of assurance of sterility. The recall affects nationwide distribution.
Pharm D Solutions is recalling specific lots of Trimix aqueous solution because the agency could not ensure the product was sterile.
Pharm D Solutions is recalling Testosterone in Grapeseed Oil Injectable because the product lacks assurance of sterility. The recall covers multiple vial sizes 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.