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 Tri-mix T108 injectable vials due to quality control observations that present a risk to sterility assurance.
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 Acetylcysteine 10% inhalant solution due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling fentanyl injectable syringes due to quality control issues that may compromise sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile injectable preparations due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Tri-mix SEST 4 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 8.3 low dose, due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including triamcinolone acetonide, due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Methylcobalamin (PF) 25 mg/mL injectable vials due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Vancomycin 25 mg/mL ophthalmic solution because quality control issues may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling Cromolyn sodium 1% inhalant solution due to sterility assurance concerns identified during an FDA inspection.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including hydromorphone/clonidine/bupivacaine, due to quality control observations that risk 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 Glycerin 72% sodium chloride injectable vials due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling dexamethasone sodium phosphate injectable vials due to quality control issues that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 20% inhalant solution due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including Quad mix 1, due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling trimethoprim/sulfadiazine excipient stock solution injections due to quality control issues that risk 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 all compounded sterile preparations within expiry due to quality control observations that present a risk to sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Acetylcysteine 10% ophthalmic solution due to quality control issues that may compromise sterility.
Martin Avenue Pharmacy is voluntarily recalling PGE 2 injectable vials due to quality control issues affecting sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling compounded sterile preparations, including cyanocobalamin, due to quality control observations that risk sterility assurance.
Martin Avenue Pharmacy is voluntarily recalling Cefazolin eye drops because quality control issues may have compromised sterility.
Martin Avenue Pharmacy is voluntarily recalling Lidocaine 2% injectable vials because quality control observations during an FDA inspection raised concerns about sterility assurance.