Class II · Moderate risk Terminated
Cefuroxime 4mg /0.4 mL (10 mg/mL), 1mL syringe, Rx only, Compounded by: Pine Pharmaceuticals 355 Riverwalk Parkway, Tonawanda, NY…
Reason Lack of Assurance of Sterility
Is Pine recalled?
685 FDA recalls mention Pine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine.
Class II · Moderate risk Terminated
Moxifloxacin in Balanced Salt Solution, Solution for Intraocular Injection, 600 mcg/0.4mL (150 mcg/0.1mL) Syringe, Rx only…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Tropi-Phen (Tropicamide 1% phenylephrine HCl 2.5%) ophthalmic solution, 15 mL multi-use Droppers, Rx only, Compounded by Pine…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate 2.5% solution for inhalation, 5mL pre-filled syringes, Rx only, Compounded by Pine Pharmaceuticals 355…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Calcium Gluconate Ophthalmic Irrigation Solution 1%, 500 mL bags, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Endophth Kit (Vancomycin 1mg/0.1 mL - Ceftazidime 2.25mg/0.1 mL), Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin 1 MG/0.1 ML Solution for Intraocular Injection, 0.8 ML Single Dose Vial, Rx only, Compounded by: Pine Pharmaceuticals…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Bevacizumab 1.25 MG/0.05 ML Solution for Injection, 1 mL syringes, Rx only, Compounded by Pine Pharmaceuticals 355 Riverwalk…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South…
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
EPINEPHrine added to 0.9% sodium chloride, 4mg/250mL (16 mcg/mL), IV Bag, RX only, Central Admixture Pharmacy Services, Inc…
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services…
Reason Lack of Assurance of Sterility:Lack of validation data for sanitization cycles
Class II · Moderate risk Terminated
norepinephrine, 16 mg, added to dextrose 5% 250 mL, IV Bag, CONCENTRATION 64 mcg/mL, Rx Only, Central Admixture Pharmacy…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
NORepinephrine 4 mg/250 mL added to 0.9% sodium chloride 16 mcg/mL, IV Bag, Rx only, Central Admixture Pharmacy Services, Inc…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
EPINEPHrine 8mg/250ml added to dextrose 5%, 32 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
EPINEPHrine added to dextrose 5%, 4mg/250ml, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
EPINEPHrine, 2 mg added to dextrose 5% 250mL, Concentration = 8 mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
EPINEPHrine 4mg/250mL added to 0.9% sodium chloride, IV Bag, RX only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd…
Reason Lack of assurance of sterility. Validation data for decontamination cycles is lacking.
Class II · Moderate risk Terminated
Norepinephrine 32 mg per 250 mL (128 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Atropine Sulfate Injection, USP 8 mg per 20 mL (0.4 mg per mL), 20 mL Multiple Dose Vials, Rx only, Manufactured for: Accord…
Reason Presence of Particulate Matter: Particulate matter identified as fiber.
Class III · Low risk Terminated
Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore…
Reason Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Class II · Moderate risk Ongoing
Norepinephrine 4 mg added to 250 mL of 5% Dextrose Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101, Columbia, MO…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
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