🍔 Food 💊 Drugs 🏥 Medical Devices
Betaxolol Ophthalmic Solution, USP 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-705-10 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Artificial Tears Solution, Lubricant Eye Drops, Polyvinyl Alcohol 1.4%, 15 mL (0.5 fl. oz.) per bottle, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-060-12 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Artificial Tears OINTMENT, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) per tube, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-062-35 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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AK-POLY-BAC brand of Bacitracin cand Polymixin B Sulfate Ophthalmic Ointment USP, 3.5 g (1/8 oz.) tube, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-238-35 Class II

Reason: CGMP Deviations:

Akorn, Inc. 20221013 Ongoing
Distributed: Nationwide in the USA
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Daptomycin for Injection 350 mg/vial 1 Single-dose vial, Rx only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, India. NDC 16729-0434-05 Class I

Reason: Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial

Accord Healthcare, Inc. 20221129 Terminated
Distributed: Nationwide within the United States
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Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 mg per 10 mL (2.5 mg per mL), 10 mL Single Dose Vial (NDC 63323-468-01), packaged in 25 Single Dose Vials per tray (NDC 63323-468-17), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Class II

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC 20221122 Terminated
Distributed: Nationwide in the USA
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Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg per 50 mL (5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-463-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-463-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Class II

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC 20221122 Terminated
Distributed: Nationwide in the USA
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Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg per 50 mL (2.5 mg per mL), 50 mL Multiple Dose Vial (NDC 63323-461-01), packaged in 25 Multiple Dose Vials per tray (NDC 63323-461-57), Rx only, Fresenius Kabi, Lake Zurich, IL 60047. Class II

Reason: Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.

Fresenius Kabi USA, LLC 20221122 Terminated
Distributed: Nationwide in the USA
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TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/mL INJECTABLE, packaged in 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. Class II

Reason: Lack of Assurance of Sterility

Northern VA Compounders PLLC 20221230 Terminated
Distributed: Nationwide in the USA
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BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, 2.5 mL Multiple-Dose vials, Rx Only, Compounded by: Akina Pharmacy, 23475 Rock Haven Way Suite 105, Sterling, VA 20166. Class II

Reason: Lack of Assurance of Sterility

Northern VA Compounders PLLC 20221230 Terminated
Distributed: Nationwide in the USA
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