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 sterile preparations, including chlorhexidine gluconate ophthalmic solution, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including sodium tetradecyl sulfate, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydrochloric acid/water for injection, 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 sterile preparations, including Diazepam, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Quad Mix injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Atropine sulfate 1 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 Tri-mix ST9-B, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix T102 injectable vials because quality control issues identified during an FDA inspection may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling Paraben water for injection because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix 2, due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including phentolamine mesylate, due to quality control issues affecting 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 sterile preparations, including Quad mix, due to quality control issues that may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling hyaluronidase injection solution due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling Hydroxyzine hydrochloride 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling benzalkonium chloride water for injection due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Voriconazole 10 mg/mL ophthalmic solution due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable 6000 mcg/mL due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Phenol 10% injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin 25 mg/mL injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chorionic gonadotropin/mannitol, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Vancomycin 50 mg/mL ophthalmic solution due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone injection solutions, due to quality control issues affecting sterility assurance.