🍔 Food 💊 Drugs 🏥 Medical Devices
Susvimo (ranibizumab injection), 100mg/mL, sold together as a) carton containing One Susvimo single-dose vial and One Susvimo initial fill needle, NDC 50242-078-55; and b) carton labeled as Susvimo Ocular Implant with Insertion Tool Assembly, containing One carrier with implant and One insertion Tool, UDI 81004259001, GTIN 00810042590014, Rx only, Genentech, Inc., A Member of the Roche Group, South San Francisco, CA 94080-4990. Class III

Reason: Defective Delivery System: Commercial implants do not meet the filed specification for the intended use, a few patients have experienced an issue with the implants that renders it non-functioning.

Genentech Inc 20221018 Terminated
Distributed: Nationwide in the USA
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Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30-count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512 Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India; NDC 62756-970-83 Class II

Reason: Presence of Foreign Substance

SUN PHARMACEUTICAL INDUSTRIES INC 20221018 Terminated
Distributed: Nationwide with the United States
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8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx Only, Mfd for: Civica, Inc. Lehi, Utah 84043, Mfd by: Exela Pharma Sciences, LLC, Lenoir, NC 28645, Carton NDC 72572-740-20, vial NDC 72572-740-1. Class I

Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Exela Pharma Sciences LLC 20221004 Terminated
Distributed: Nationwide within the United States
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8.4% Sodium Bicarbonate Injection, USP 50 mEq/50 mL (1 mEq/mL) 50 mL Single Dose Vials, packaged in cartons of 20 vials, Rx only, Manufactured and Distributed by: Exela Pharma Sciences, LLC Lenoir, NC 28645. Carton NDC 51754-5001-5, vial NDC 51754-5001-1 Class I

Reason: Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration

Exela Pharma Sciences LLC 20221004 Terminated
Distributed: Nationwide within the United States
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Quinapril and Hydrochlorothiazide Tablets, USP 20mg/12.5mg, 90 Tablets bottles Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, Made in India, NDC 65862-162-90 Class II

Reason: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.

Aurobindo Pharma USA Inc. 20221005 Completed
Distributed: Nationwide
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Fondaparinux Sodium Injection, USP, 7.5 mg per 0.6 mL, Single Dose, Prefilled Syringe, Distributed by: AuroMedics Pharma LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520. Made in India. NDC 55150-232-10 (carton)NDC 55150-232-00 (syringe) Class II

Reason: Subpotent Drug: Out of specification for assay

AuroMedics Pharma LLC 20220930 Terminated
Distributed: Nationwide in the USA
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Atenolol Tablets, USP, 25 mg, 1000-count bottle, Rx only, Manufactured by: ALPHAPHARM PTY LTD, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC 60429-027-10 Class I

Reason: Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets

Golden State Medical Supply Inc. 20220929 Terminated
Distributed: USA Nationwide
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Pyridostigmine Bromide Oral Solution, USP 60 mg/5 mL Delivers 5 mL, packaged in 5mL unit-dose cup, Rx only, Dist. by: VistaPharm, NDC 66689-406-01 Class II

Reason: cGMP Deviations: Out of specification for assay of one of the preservative ingredients.

VistaPharm, Inc. 20220930 Terminated
Distributed: USA Nationwide
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Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Green Tea and Aloe, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle, and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50. Class II

Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

Ultra Chem Labs Corp 20220815 Terminated
Distributed: Nationwide
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Proton Armor, Anti-Microbial Alcohol-Free Foaming Hand Sanitizer, kills 99.99% of germs, Odor Free, Family Safe, No Gels, Water Based, 24 Hour Germ Protection with Moisturizers for Sensitive Skin, a) 8 oz bottle, b) 32 oz bottle and c) 1.7 fl oz or 50 mL bottle, Supplier details: Ultra Chem Labs, Ontario, CA, Active Ingredients - Benzalkonium Chloride 0.13% (antimicrobial), ULS 8357 0.33% (antimicrobial shield), NDC 79208-001-50. Class II

Reason: Chemical Contamination and CGMP Deviations: trace amounts of methanol found in one of the components during the manufacturing process.

Ultra Chem Labs Corp 20220815 Terminated
Distributed: Nationwide
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