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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 2921–2940 of 17,723 recalls

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 IITerminated

Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 23155-0490-01; MFG: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816; Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC #: 70518-3493-00.

RemedyRepack Inc.

Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency.

December 5, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 72-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-02, UPC 3-0766-0746-50-8

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-06, UPC 3-0766-0745-85-3

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewable tablets, 72-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-83, UPC 3-0766-0746-50-8

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0228-01, UPC 3-0766-0746-80-5

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable Tablets, packaged in 160-count bottles, Dist. by: GSK CH, Warren, NJ 07059. NDC: 0135-0118-14, UPC 3-0766-0746-10-2

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 265-count bottle, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-05, UPC 3-0766-3072-14-7

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IICompleted

TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewable Tablets, packaged in 12-count roll, Dist. by: GSK CH, Warren, NJ 07059. NDC: 135-0181-03, UPC 3-0766-0746-70-6

GlaxoSmithKline Consumer Healthcare Holdings LLC

Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.

December 2, 2022 · DrugView details →

Class IITerminated

Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185-88), b) 500-count bottles (NDC 62756-185-13), c)1000-count bottles (NDC 62756-185-18), Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gujarat, India.

SUN PHARMACEUTICAL INDUSTRIES INC

Presence of foreign substance

December 1, 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 IITerminated

FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Free, Single Use 50 ml Cassette, Rx Only, Repackaged by OurPharma, LLC. 2512 S. City Lake Rd. Fayetteville, AR 72701, 1-833-290-2654, NDC 73013-001-01

OurPharma LLC

Underfilled units.

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 IITerminated

0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC 0264-5802-00 B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA 1-800-227-2862

B. Braun Medical, Inc.

Lack of sterility assurance: Bags have the potential to leak.

November 25, 2022 · DrugView details →

Class IITerminated

Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick, NJ 08816, NDC 23155-490-01

Heritage Pharmaceuticals Inc

Subpotent Drug

November 23, 2022 · DrugView details →

Class IITerminated

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.

Fresenius Kabi USA, LLC

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

November 22, 2022 · DrugView details →

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