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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 841–860 of 1,000 recalls

Class IITerminated

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 100 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0130-5

IBSA PHARMA INC

Subpotent Drug

January 30, 2023 · DrugView details →

Class IITerminated

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 13 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0105-5

IBSA PHARMA INC

Subpotent Drug

January 30, 2023 · DrugView details →

Class IITerminated

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 44 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0113-5

IBSA PHARMA INC

Subpotent Drug

January 30, 2023 · DrugView details →

Class IITerminated

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 50 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0115-5

IBSA PHARMA INC

Subpotent Drug

January 30, 2023 · DrugView details →

Class IITerminated

TIROSINT - SOL (levothyroxine sodium) Oral Solution, 25 microgram/mL; 6 pouches x 5 ampules, Rx Only; Manufactured for IBSA Pharma Inc. by: IBSA Institut Biochimique SA, 6912 Pazzallo, Switzerland; Distributed by: IBSA Pharma Inc., Parsippany, NJ 07054; NDC 71858-0110-5

IBSA PHARMA INC

Subpotent Drug

January 30, 2023 · DrugView details →

Class IITerminated

Verapamil Hydrochloride Extended-Release Tablets, USP, 120 mg, Rx Only, 100 Tablets per Carton (10 x 10), Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC Carton: 60687-493-01; NDC Unit Dose: 60687-493-11.

Amerisource Health Services LLC

Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.

January 27, 2023 · DrugView details →

Class IITerminated

Ohm Sanitizer Spray (alcohol (ethyl alcohol) 80% v/v, 8 FL OZ (237 ML) bottles.

Urban Electric Power

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

January 17, 2023 · DrugView details →

Class IITerminated

Ohm Hand Sanitizer (alcohol (ethanol) 70 % v/v), packaged in a) 2 FL OZ (60 ML), b) 3 FL OZ (88 ML) bottles, c) 10 FL OZ (295 ML) bottles, d)12 FL OZ (355 ML) bottles, e)16 FL OZ (473 ML) bottles, f) 64 FL OZ (1892 ML) bottles, g) 128 FL OZ (3785 ML) bottles

Urban Electric Power

CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.

January 17, 2023 · DrugView details →

Class IITerminated

Allopurinol Tablets 100mg, USP, 90-count bottles, Rx Only, 90, Mfg: Accord Healthcare, Inc; Durham, NC, PREFERRED Pharmaceuticals, Inc., The Physician's Solution, Prod#: 68788-7383-09.

Preferred Pharmaceuticals, Inc.

Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.

January 16, 2023 · DrugView details →

Class IITerminated

Diltiazem Hydrochloride Extended-Release Capsules, USP, 360 mg; Rx only; 90-count bottles, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389350, Gujarat, India; Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 47335-679-81

SUN PHARMACEUTICAL INDUSTRIES INC

Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.

January 13, 2023 · DrugView details →

Class IITerminated

S2 Racepinephrine Inhalation Solution, USP 2.25% Bronchodilator 30x0.5 mL Sterile Unit-of-Use Vials each in a foil pouch, Manufactured By: Nephron West Columbia, SC 29172, NDC 0487-5901-99 UPC 3 04875 90199 9

Nephron Sc Inc

Short Fill

January 13, 2023 · DrugView details →

Class IITerminated

Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator (racephedrine, USP 11.25), 30x0.5 mL Sterile Vials each in a foil pouch, NDC 0487-2784-01 UPC 3 04872 78401 4

Nephron Sc Inc

Short Fill

January 13, 2023 · DrugView details →

Class IITerminated

Allopurinol Tablets USP, 100 mg, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. India. NDC 16729-134-01

Accord Healthcare, Inc.

Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.

January 12, 2023 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100 mL Single-Dose Container bag, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th St. Extension, W. Columbia, SC 29172, NDC: 0487-4301-10, UPC 3 04874 30110 3.

Nephron Sc Inc

CGMP Deviations: potential for trace amounts of product carryover.

January 12, 2023 · DrugView details →

Class IITerminated

Sterile Water for Injection, USP, For Drug Diluent Use Only, 5 mL Single-Dose Vial, packaged in 30 x 5 mL Single-Dose Vials per carton, Rx Only, Nephron Pharmaceuticals Corporation, 4500 12th Street Extension, W. Columbia, SC 29172, NDC 0487-6105-01, UPC 3 04876 10501 3.

Nephron Sc Inc

CGMP Deviations: potential for trace amounts of product carryover.

January 12, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, packaged in (a) 100-count bottle, NDC 68001-501-00; (b) 500-count bottle, NDC 68001-501-03. Manufactured by Alkem Laboratories Ltd., India. For BluePoint Laboratories

Amerisource Health Services LLC

Failed Dissolution Specifications: This recall is being initiated in support of the recall by the manufacturer which included lots that were packaged for BluePoint Laboratories.

January 11, 2023 · DrugView details →

Class IITerminated

Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syringe, 6 x 5 syringe carton, Rx Only, Nephron 503B outsourcing facility, 4500 12th Street Extension, West Columbia, SC 29172, NDC: 69374-924-05

Nephron Sterile Compounding Center LLC

Lack of Assurance of Sterility

January 6, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 25 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-590-01.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 100 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-01.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

Class IITerminated

Metoprolol Succinate Extended-Release Tablets, USP 50 mg, Rx Only, 500 Tablets per bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Parsippany NJ 07054, NDC 67877-591-05.

Ascend Laboratories, LLC

Failed Dissolution Specification

January 5, 2023 · DrugView details →

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