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 Histamine 0.55 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.01% ophthalmic solution due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including ophthalmic ointment base, due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded hydromorphone and bupivacaine injections due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T50 injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST2 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling PGE 4 injectable vials because quality control issues identified during an FDA inspection present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 0.5% ophthalmic solution due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tobramycin eye drops due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 10 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including morphine/bupivacaine, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Tri-mix T101, due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST9-A injectable vials 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 observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded morphine sulfate injectables due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Testosterone cypionate 150 mg/mL injections due to quality control issues that may compromise 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 T105 injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling veterinary injection suspensions due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix ST5 injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T106 injectable vials because FDA inspection observations raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Prednisolone acetate 50 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling dihydroergotamine mesylate injections due to quality control issues that may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.