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 PGE 3 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 compounded Triamcinolone acetonide injections due to quality control observations that risk 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 sodium tetradecyl sulfate 1% injectable vials due to quality control observations that present a risk to 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 compounded sterile preparations due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded polyhexamethylene biguanide eye drops due to quality control issues that risk 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 Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Hydroxocobalamin 5 mg/mL injectable vials due to quality control issues that may affect 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 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 due to quality control observations that present a risk to 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 PGE 2 injectable vials 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 Lidocaine (PF) 1% injectable vials due to quality control issues that may compromise 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 Tri-mix T105 injectable vials due to quality control observations that present a risk to 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 compounded sterile preparations, including triamcinolone injection solutions, due to quality control issues affecting 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 Phenylephrine 10% ophthalmic solution due to quality control issues that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including chlorhexidine gluconate ophthalmic solution, due to quality control issues affecting sterility assurance.