FDA (Drugs) recall action 64879
The FDA (Drugs) publishes a recall like this one as 78 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 78 pages.
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes..
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.
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrogen Peroxide Injection due to a lack of assurance of sterility in compounded and repackaged products.
Green Valley Drugs is recalling 295 vials and syringes of Betamethasone Combination Injection because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling Betamethasone Acetate and Betamethasone Sodium Injection because the pharmacy lacked assurance of sterility in its quality control processes.
Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling 203 vials of Sodium Tetradecyl Sulfate Injection due to lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 335 vials of Sodium Bicarbonate and Lidocaine Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling Dimethyl Sulfoxide (DMSO) Injection products due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 2,682 vials of Ascorbic Acid Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 273 vials of Dexpanthenol Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling Medroxyprogesterone Acetate Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling 1,423 vials of Triamcinolone Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 950 syringes of Sodium Chloride and Dexamethasone Injection due to lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 197 vials of Magnesium Chloride Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling Cyclosporine Injection products due to a lack of assurance of sterility and quality control concerns.
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,213 vials of Sodium Bicarbonate Injection due to a lack of assurance of sterility.
Green Valley Drugs is recalling Glycerin/Lidocaine/Epinephrine Injection because the pharmacy could not ensure the sterility of the compounded products.
Green Valley Drugs is recalling Methylprednisolone and Dexamethasone Injections due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling Bupivacaine and Dexamethasone Injection due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling 208 vials of Zinc Sulfate Injection because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling BET-ACE-LIDO-6-2 Injection products because the pharmacy could not ensure the sterility of the compounded items.
Green Valley Drugs is recalling L-Glutathione Injection vials because the FDA identified a lack of sterility assurance and quality control concerns.
Green Valley Drugs is recalling 679 vials of B-Complex Injection products nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling Lidocaine Injection products because the pharmacy could not ensure the sterility of the compounded and repackaged items.
Green Valley Drugs is recalling Biotin Injection products because the pharmacy could not ensure the sterility of the compounded items.
Green Valley Drugs is recalling Acetylcysteine Injection vials because the pharmacy could not ensure the products were sterile.