December 6, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd. Colvale-Barde
Hazard: Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#:60505-0101-4 Manufactured by: Apotex Inc.,
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#: 60505-0084-1, b)100-count bottle, NDC#:60
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, NDC#:60505-0083-2; b) 1000-count bottle, NDC
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
December 6, 2023DrugsFDA
Apotex Corp. recalls Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#
Hazard: Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL) dropper bottles, Sterile, Distributed By
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, 0.3%); 0.33 FL OZ (10 mL) dropper bottle, S
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bottles, 0.5 FL OZ (15 mL) dropper bottles, St
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 FL OZ (15 mL) dropper bottles, Sterile, Dist
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (15 mL) dropper bottle, Sterile, Distributed
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Cardinal Health Inc. recalls LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls ELCYS (cysteine hydrochloride injection), USP, 500 mg/10mL (50 mg/mL), 10x10 mL Single Dose Sterile Vials, For Intraveno
Hazard: Presence of Particulate Matter: Silicone
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls Midazolam in 0.8% Sodium Chloride Injection 100 mg/100 mL (1mg/mL), 100 mL Single-Dose Vial, 25 count carton, Ready to U
Hazard: Presence of Particulate Matter: Silicone
November 29, 2023DrugsFDA
Exela Pharma Sciences LLC recalls 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1mEq/mL), a) 20x50 mL Single Dose Vials (Vial NDC 51754-5001-1; Ca
Hazard: Presence of Particulate Matter: Silicone
November 29, 2023DrugsFDA
ITF PHARMA INC recalls Tiglutik (riluzole) Oral Suspension 50 mg/10 mL (5 mg/mL), 600 mL (two bottles/300 mL each), RX only, Manufactured for I
Hazard: Failed Viscosity Specifications: Out-of-specification test results for viscosity
November 29, 2023DrugsFDA
NCS Healthcare of Kentucky Inc recalls Lisinopril Tablets USP 20 mg, packaged in a) 15-count blister card (NDC 0615-7718-05), b) 30-count blister card (NDC 061
Hazard: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
November 29, 2023DrugsFDA
NCS Healthcare of Kentucky Inc recalls Buspirone Hydrochloride Tabs USP 10 mg, packaged in a) 15-count blister card (NDC 0615-7718-05) b) 30-count blister card
Hazard: Presence of Foreign Tablets: Potential of stray tablet(s) of Amlodipine Besylate 10 mg Tablet within the recalled lots
November 29, 2023DrugsFDA
Glenmark Pharmaceuticals Inc., USA recalls Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Packaged as (a) 30-count bottle, NDC 68462-390-30; (b) 1000-c
Hazard: Failed Impurities/Degradation Specifications:Out of Specification result reported for the test of organic impurities for the drug product,at the 18 month time point in long term stability study (25¿C/60% RH).
November 29, 2023DrugsFDA
Integrity Bio-Chemicals LLC recalls Integrity Biochem HSC 70-VA, Alcohol Antiseptic 70%, Hand Sanitizer, Vanilla Scented Topical Gel 208.19L (55 gallons)- d
Hazard: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
November 29, 2023DrugsFDA
Integrity Bio-Chemicals LLC recalls Integrity Biochem HSC70-LV, Alcohol Antiseptic 70%, Hand Sanitizer, Lavender Scented Topical Gel 208.19L (55 gallons) dr
Hazard: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
November 29, 2023DrugsFDA
Integrity Bio-Chemicals LLC recalls Integrity Biochem HSC 70-LM, Alcohol Antiseptic 70%, Hand Sanitizer, Lemon Scented Topical Gel, 208.19 L (55 gallons) dr
Hazard: CGMP Deviation: Third party test results showing a presence of acetal and acetaldehyde at levels above USP specified amounts.
November 29, 2023DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUG
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 29, 2023DrugsFDA
The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories recalls Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livoni
Hazard: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
November 22, 2023DrugsFDA
Family Medical Supply Inc recalls Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C; b) D; c) E; d) H; e) M; f) M6, Rx only, Fa
Hazard: cGMP Deviations
November 22, 2023DrugsFDA
Omega & Delta Co., Inc. recalls Equate Hand Sanitizer (Ethyl Alcohol 62%), 7.5 FL.OZ. (221 mL) UPC 6 81131 05961 9
Hazard: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
November 22, 2023DrugsFDA
Omega & Delta Co., Inc. recalls DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, 8FL OZ (237mL) bottle, Hecho en Puerto Rico por: Omega
Hazard: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
November 22, 2023DrugsFDA
Omega & Delta Co., Inc. recalls DOP Instant Hand Sanitizer (Ethyl Alcohol 65%) with Moisturizers, Original, 4FL OZ (118 ml) bottle, Hecho en Puerto Rico
Hazard: Sub Potent and Super Potent Product: During an impact assessment of the DOP Hand Sanitizer product, it was identified that several lots distributed did not comply with the finished good acceptance criteria established.
November 15, 2023DrugsFDA
Pfizer Inc. recalls 2% Lidocaine HCl Injection, USP, 100mg/5mL(20mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector
Hazard: Presence of Particulate Matter: identified as glass.
November 15, 2023DrugsFDA
Pfizer Inc. recalls 1% Lidocaine HCl Injection, USP, 50mg/5mL(10mg/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial and injector
Hazard: Presence of Particulate Matter: identified as glass.
November 15, 2023DrugsFDA
Pfizer Inc. recalls 4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5mEq/mL), Glass ABBOJECT Unit of Use Syringe, packaged as 1 vial a
Hazard: Presence of Particulate Matter: identified as glass.