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 PGE 1, due to quality control observations that risk 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 Tri-mix injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Pilocarpine 0.25% ophthalmic solution due to quality control issues that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Cefazolin ophthalmic solution 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 Triamcinolone acetonide injections due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Bupivacaine hydrochloride 0.25% injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling bacteriostatic water for injection due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling fentanyl/bupivacaine injectable syringes 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 compounded sterile preparations, including Hyaluronidase base vehicle, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Polyhexamethylene biguanide 2% stock solution, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyclosporine/corn oil, due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including calcium chloride, due to quality control observations that risk 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 T25 injectable vials because quality control observations during an FDA inspection presented a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Nalbuphine 10 mg/mL injection solution due to quality control observations that present a risk to sterility assurance.