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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 9961–9980 of 17,793 recalls

Class IIITerminated

HYDROmorphone HCl in 0.9% Sodium Chloride Injection, 1 mL Total Volume 1 mg per mL, For IV Use Only, Rx Only, Compounded by: PharMEDium Services LLC. 913 N Davis Ave Cleveland, MS 38732, NDC# 61553-165-78

Pharmedium Services, LLC

Labeling: Incorrect or Missing Lot and/or Exp. Date

September 26, 2017 · DrugView details →

Class IITerminated

methylPREDNIsolone ACETATE, 40 MG/ML INJECTION SUSPENSION, 10 ML Vial, RXQ Compounding, Athens, OH --- NDC: 70731-0936-10

RXQ Compounding LLC

Lack of Assurance of Sterility; autoclave parameters were not correct for one of two autoclaves used to sterilize the product.

September 25, 2017 · DrugView details →

Class IIITerminated

Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3 trays per case containing a total of 5 mL x 30 Unit Dose Cups per case (NDC 68094-301-62), Rx only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080.

Precision Dose Inc.

Subpotent Drug: low out of specification results.

September 25, 2017 · DrugView details →

Class IIITerminated

Esterified Estrogens & Methyltestosterone Tablets, USP 1.25 mg/2.5 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-172-01

Amneal Pharmaceuticals, Inc.

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

September 25, 2017 · DrugView details →

Class IIITerminated

Ampicillin for Injection, USP, 500 mg per vial, single vial (NDC 0781-3407-78) packaged in 10-count shrink wrap packs (NDC 0781-3407-95), Rx only, Manufactured in Austria by Sandoz GmbH or Sandoz Inc., Princeton, NJ 08540.

Sandoz Inc

Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.

September 25, 2017 · DrugView details →

Class IIITerminated

Esterified Estrogens & Methyltestosterone Tablets, USP 0.625 mg/1.25 mg, 100-count bottles, Rx Only, Manufactured by: Ammeal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Seton Pharmaceuticals Manasquan, NJ 08736, NDC 13925-171-01

Amneal Pharmaceuticals, Inc.

Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.

September 25, 2017 · DrugView details →

Class IIITerminated

Mobic (meloxicam) tablets, 15 mg, package in 100-count bottle, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA, Lic. from: BI Int'l GmbH, Made in Italy, NDC 0597-0030-01

Boehringer Ingelheim Pharmaceuticals, Inc.

Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.

September 22, 2017 · DrugView details →

Class IITerminated

Medline Suture Removal Tray. Sterile. Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline General Purpose Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Vitrectomy CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline IV Start Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Vaginal Delivery CDS Pack, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Suture Removal Tray, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Abdominal Surgery II Pack-LF, Sterile, Single Use Only. Packaged in USA for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline General Purpose Instrument Set, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Central Line Dressing Change Tray Kit, Sterile, Single use only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Incision Drainage Tray, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Suture Removal Kit, Sterile, Single Use Only. Packaged in Mexico for Medline Industries, Inc., Mundelein, IL 60060

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

Class IITerminated

Medline Newborn Kit. Packaged for Medline Industries, Inc., Northfield, IL 60093

Medline Industries Inc

Subpotent Drug:The titratable iodine contained in the Povidone-Iodine prep pads is below label claim of 0.85%.

September 21, 2017 · DrugView details →

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