FDA (Drugs) recall action 69152
The FDA (Drugs) publishes a recall like this one as 118 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 118 pages.
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
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.
Martin Avenue Pharmacy is voluntarily recalling compounded Hydromorphone HCl injectable syringes due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 1 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Dexamethasone sodium phosphate 4 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because quality control issues may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 2 mg/mL injectable vials due to quality control issues that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 1 mg/mL injectable vials due to quality control issues that may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix, due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate syringes due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Lidocaine (PF) 1% injectable vials due to quality control issues that may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Alprostadil alcohol injectable vials because quality control observations during an FDA inspection presented a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Lidocaine 1% injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST1 injectable vials because FDA inspection findings raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Phenylephrine 1% injectable vials because quality control issues may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling sodium tetradecyl sulfate 1% injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tetracycline 250 mg powder kits due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials because FDA inspection findings raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 250 mg/mL injections due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations of Sodium tetradecyl sulfate due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded Testosterone cypionate 200 mg/mL injections due to quality control observations that present a risk to sterility assurance.