Class III · Low risk Terminated
Atropine Sulfate Ophthalmic Solution, USP 1%, 5 mL bottles, Rx only, Manufactured for: Somerset Therapeutics, LLC. Somerset, NJ…
Reason Failed Impurities/Degradation Specifications
Is Atropine recalled?
132 FDA recalls mention Atropine. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Atropine.
Class I · High risk Ongoing
Atropine Sulfate Injection, USP 1 mg/10 mL (0.1 mg/mL), Lifeshield, Glass ABBOJECT Unit of Use Syringe, Rx Only, 10 mL Syringe…
Reason Presence of Particulate Matter; identified as glass
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 II · Moderate risk Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, packaged in a) 2 mL bottles b) 5 mL bottles…
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution, USP 1%, For Topical Application To The Eye, 2 mL bottle, Sterile, Rx only, Distributed by…
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk Terminated
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg/40mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/20mg/2mg/0.2mg/mL INJECTABLE, 2.5 mL Multiple-Dose…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/4mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/1mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/30mg/2mg/0.4mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10mcg/30mg/2mg/0.2MG/ML INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/2mg/0.2mg/mL INJECTABLE, packaged in 2.5 mL…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Atropine sulfate 0.05%, 1ML dropper, and Atropine sulfate 0.01%, 1 ML dropper, Rx Only, Pharmacy Innovations, 2936 W 17th St…
Reason Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Class II · Moderate risk Ongoing
PAP/PHEN/PROSTAG/ATROPINE INJ 150MG/7.5MG/75MCG/1MG bottle solution, 5 mL vials, Rx only, Vital Care Compounder, 115 S. 40th…
Reason Lack of Assurance of Sterility: FDA inspection found the recalled products were produced in a manner than cannot guarantee the sterility of the…
Class II · Moderate risk Terminated
Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in 5 x 3 mL Pre-Filled Syringes per carton, 6 x 5…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Completed
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-2 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 60 mcg/mL Atropine 0.2 mg/mL Multi-Dose 10 mL Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Formula F9 Papaverine 0.9 mg/mL Phentolamine 0.1 mg/mL PGE 20 mcg/mL Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Formula F2 Papaverine 9 mg/mL Phentolamine 1 mg/mL Alprostadil 10 mcg/mL Atropine 0.1 mg/mL, Multi-Dose 10 mL vial, Rx Only…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
Formula F1 Papaverine 1.8 mg/mL Phentolamine 0.2 mg/mL Alprostadil 18 mcg/mL Atropine 0.02 mg/mL, Packaged as a)2.5 mL Multi-Dose…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700…
Reason Lack of assurance of sterility.
Class II · Moderate risk Completed
QM-4 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 300 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia…
Reason Lack of assurance of sterility.
Class II · Moderate risk Terminated
Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55
Reason cGMP deviations: Temperature abuse
Class II · Moderate risk Terminated
Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly…
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