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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 41–60 of 1,000 recalls

Class ITerminated

Easy Care first aid Burn Cream (benzalkonium chloride 0.13% and lidocaine hydrochloride 0.5%), 0.9 g (0.03 oz) packets packaged in boxes of 10, Treatment for Burns, Made in China for Adventure Ready Brands, 944 Industrial Park Rd., Littleton, NH 03561, NDC 90107-0210, Product # 9999-1515

GFA Production Xiamen Co. Ltd.

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

December 23, 2022 · DrugView details →

Class ITerminated

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton, Rx only, Distributed by: Hospira, Inc., Lake Forest, IL 60045. NDC Vial 0409-3515-11; NDC Carton 0409-3515-01

Pfizer Inc.

Presence of Particulate Matter: Glass particulate matter detected in injectable.

December 22, 2022 · Drug

View details →

Class ITerminated

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, 1 KG amber glass bottle in a vacuum sealed pouch, Rx only, Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901. Product Code EP130

Spectrum Laboratory Products, Inc.

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

December 19, 2022 · DrugView details →

Class ITerminated

Epinephrine (L-Adrenaline), USP, CAS 51-43-4, Packaged in amber glass bottles in a vacuum sealed pouch as (a)100 G; (b)1 G, (c) 25 G, (d) 5 G; Rx only. Repackaged by Spectrum Chemical Mfg. Corp. Gardena, CA 90248; New Brunswick, NJ 08901.

Spectrum Laboratory Products, Inc.

Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product

December 19, 2022 · DrugView details →

Class ITerminated

Advil Liqui Gels (minis), Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Pfizer, Madison, NJ 07940, UPC 3 0573 1769 13 5

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

December 6, 2022 · DrugView details →

Class ITerminated

Advil Liqui Gels, Solubilized ibuprofen capsules, 200mg, Pain Reliever Fever Reducer (NSAID), 200 liquid filled capsules, Distributed by: Pfizer, Madison, NJ 07940, UPC 3 0573 0169 49 3

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

December 6, 2022 · DrugView details →

Class ITerminated

Advil (ibuprofen) Tablets, 200 mg, packaged as a) 360-count bottles (UPC 3 0573 0154 60 4), and b) 200-count bottles (UPC 3 0573 0154 21 5), Pfizer, Madison, NJ 07940

Glaxosmithkline Consumer Healthcare Holdings DBA Haleon

Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back

December 6, 2022 · DrugView details →

Class ITerminated

Iohexol (300 mg Iodine/mL), 2.4 g Iodine/8 ml, Total Volume 8 ml in 10 ml syringe, 5-count syringes packaged in a bag labeled as Omnipaque (iohexol) 300 mg I/mL, 2.4g Iodine/8 mL in a 10 mL syringe, Compounded with GE Healthcare product, Each mL contains (647 mg) of iohexol as 300 mg of organically bound iodine, 1.21 mg tromethamine, and 0.1 mg edetate calcium disodium, For Injection or oral use; Rx Only, BayCare Central Pharmacy, 7802 Telecom Parkway, Temple Terrace, FL 33637.

BayCare Integrated Service Center, LLC /dba BayCare Central Pharmacy

Labeling: Label Error on Declared Strength: syringes mislabeled as 300 mg iodine/mL contained product 350 mg iodine/mL

December 1, 2022 · DrugView details →

Class ITerminated

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

Accord Healthcare, Inc.

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

November 29, 2022 · DrugView details →

Class ITerminated

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.

Exela Pharma Sciences LLC

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

November 28, 2022 · DrugView details →

Class ITerminated

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.

Exela Pharma Sciences LLC

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

November 28, 2022 · DrugView details →

Class ITerminated

Octreotide Acetate Injection 500 mcg/mL, 10 x 1 mL Single-Dose Unit-of-Use Syringes, For Subcutaneous or Intravenous Use, Rx Only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., Made in Italy, NDC: 67457-246-00 (syringe), 67457-246-01 (carton).

Viatris Inc

Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.

October 7, 2022 · DrugView details →

Class ITerminated

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

Exela Pharma Sciences LLC

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

October 4, 2022 · DrugView details →

Class ITerminated

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.

Exela Pharma Sciences LLC

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

October 4, 2022 · DrugView details →

Class ITerminated

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

Golden State Medical Supply Inc.

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

September 29, 2022 · DrugView details →

Class ITerminated

Antica Farmacista Hand Sanitizer Ocean Citron (ethyl alcohol, denatured 65%) packaged in 473 mL/16 fl. oz. bottles, Dist. By Antica Farmacista Seattle, WA 98122 UPC 8 47005 00450 9

Salon Technologies International Inc

Chemical Contamination: product found to contain benzene

September 14, 2022 · DrugView details →

Class ITerminated

PROPOFOL Injectable Emulsion, 1 g/100 mL (10 mg/mL), packaged in 100 mL glass fliptop vial (NDC 0409-4699-54) further packaged in a tray of 10 vials (NDC Carton: 0409-4699-24), Rx only, Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Pfizer Inc.

Presence of particulate matter

August 22, 2022 · DrugView details →

Class ITerminated

Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.0%, Homosalate 6.0%, Octocrylene 6.0%, packaged in Net Wt 6 oz. aluminum spray can, Distributed by: Edgewell Personal Care Brands, LLC, Shelton, CT 06484, UPC 0 79656 04041 8

Edgewell Personal Care Brands, LLC

Chemical contamination: presence of benzene

July 29, 2022 · DrugView details →

Class ITerminated

SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack within a carton, Distributed by: Distributor RFR, LLC, (800) 519-0204 Miami 33172 FL, USA; UPC 0 705632 523285

Distributor RFR, LLC.

Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.

July 22, 2022 · DrugView details →

Class ITerminated

SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per carton, Formulated by: Male FX Labs, Bangor, ME, ASIN X0024468I9.

Ultra Supplement LLC

Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.

July 21, 2022 · DrugView details →

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