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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Other Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Erythromycin Ophthalmic Ointment USP, 0.5%, Net Weight: 1 g per tube (50 unit-dose tubes per carton), Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-31

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Other Drugs Nationwide View Details →

Proparacaine Hydrochloride Ophthalmic Solution, USP 0.5%, 15 mL per bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Distributed By: MWI Boise, ID 83705, NDC: 13985-611-15

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 60687-586-01 (Individual Dose NDC: 60687-586-11)

Amerisource Health Services

Class I - Dangerous

Failed Impurities/Degradations Specifications

Dec 20, 2022 Prescription Drugs Nationwide View Details →

Neomycin and Polymyxin B Sulfates, and Bacitracin Zinc Ophthalmic Ointment, USP, Net Wt. 3.5 g (1/8 oz.), Rx Only, Manufactured by: Akorn, INC., Lake Forest, IL 60045. NDC: 17478-235-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

PAREMYD (hydroxyamphetamine hydrobromide/ tropicamide ophthalmic solution) 1%/0.25%, 15 mL per dropper bottle, Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-704-12

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

SINUVA (mometasone furoate) sinus implant, 1350 mcg, 1 implant per pouch, Rx Only, intersect ENT, 1555 Adams Drive, Menlo Park, CA 94025, NDC 10599-003-01.

Intersect ENT

Class I - Dangerous

Failed Dissolution Specification; product did not meet the average 24-hour drug release rate (dissolution) specification stability time point at 9 months.

Jan 4, 2023 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

ERYTHROMYCIN OPHTHALMIC OINTMENT USP 0.5%, Net Weight: 3.5g (1/8 oz) per tube, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-070-35

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Timolol Maleate Ophthalmic Solution, USP, 0.5%, Packaged in (a) 5 mL dropper bottle, NDC 17478-288-10; (b) 10 mL dropper bottles: NDC 17478-288-11; (c) 15 mL dropper bottles, NDC 17478-288-12; Rx Only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045.

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Cromolyn Sodium Ophthalmic Solution, USP 4%, 10mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-291-11

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per dropper bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-105-05

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Compounded Drugs Nationwide View Details →

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.

Fresenius Kabi USA

Class I - Dangerous

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

Nov 22, 2022 Prescription Drugs Nationwide View Details →

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.

Fresenius Kabi USA

Class I - Dangerous

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

Nov 22, 2022 Prescription Drugs Nationwide View Details →

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

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Compounded Drugs Nationwide View Details →

Ciprofloxacin Ophthalmic Solution, USP 0.3% (Ciprofloxacin HCl), 2.5mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-714-25

Akorn

Class I - Dangerous

CGMP Deviations:

Oct 13, 2022 Prescription Drugs Nationwide View Details →