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.
Green Valley Drugs is recalling Dimethyl Sulfoxide (DMSO) Injection products due to a lack of assurance of sterility and quality control concerns.
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 65 vials of Metoprolol Injection due to lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling 251 vials of DMPS Injection nationwide due to a lack of assurance of sterility and quality control concerns.
Green Valley Drugs is recalling Amikacin Injection because the pharmacy could not ensure the sterility of the compounded products. The recall covers all strengths and presentations of the drug.
Green Valley Drugs is recalling 318 vials of Sodium Chloride Injection due to a lack of assurance of sterility and quality control concerns.
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 3,289 vials of Ketorolac Injection nationwide 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 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 679 vials of B-Complex Injection products nationwide due to a lack of assurance of sterility and quality control concerns.
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 10,684 vials of ED Mix Injections nationwide due to a lack of assurance of sterility in compounded 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 Manganese Sulfate Injection because the pharmacy could not ensure the sterility of the compounded products.
Green Valley Drugs is recalling 720 syringes of Methylprednisolone, Lidocaine, and Sodium Chloride Injection because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling Modified Myers Cocktail Injection vials because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling Estradiol Cypionate Injection because the pharmacy could not ensure the products were sterile. The recall covers all strengths and presentations distributed nationwide.
Green Valley Drugs is recalling Phenylephrine Injection vials because the pharmacy could not ensure the products were sterile.
Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling Polidocanol Injection vials nationwide 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.
FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Procaine Hydrochloride Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
Green Valley Drugs is recalling Methylprednisolone Acetate Injection products because the company could not ensure the sterility of the compounded and repackaged items.
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 Furosemide Injection vials because the pharmacy could not ensure the products were sterile. The recall covers 227 vials distributed nationwide.
Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.