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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 9281–9300 of 17,793 recalls

Class IITerminated

HYDROmorphone 0.2mg/mL. (Hydromorphone HCL (USP) 20 mg, 0.9% Sodium Chloride (USP) QS 100 mL) Volume: 100mL. Single dose bag. Advanced Pharma, 9265 Kirby Dr., Houston,077054 TX. NDC 15082-221-10

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

June 12, 2018 · DrugView details →

Class IITerminated

Midazolam 1 mg/mL (Midazolam HCL (USP) 55 mg, 0.9% Sodium Chloride, (USP) QS 55 mL) Volume: 55mL. Single dose syringe. Advanced Pharma, 9265 Kirby Dr., Houston TX 77054. NDC 15082-401-76

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

June 12, 2018 · DrugView details →

Class IITerminated

Vancomycin 1.25gm in D5W 250 mL. ( Vancomycin HCL (USP) 1.25 gm, 5% Dextrose Inj. (USP) 250 mL) Volume: 262 mL. Single dose bag. Avella Specialty Pharmacy, 24416N 19th Avenue, Phoenix, AZ 85085. NDC 42852-617-25

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

June 12, 2018 · DrugView details →

Class IITerminated

EPINEPHrine (USP) 4 mg, 0.9% Sodium Chloride (USP) 250 mL Volume: 254 mL single dose bag. Avella of Houston, 9265 Kirby Dr., Houston, TX 77054. NDC 42852-823-25.

Avella of Deer Valley, Inc. Store 38

Lack of Assurance of Sterility: Potential leakage of bags.

June 12, 2018 · DrugView details →

Class IITerminated

Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.

BioDiagnostic International

CGMP Deviations: Products not manufactured under current good manufacturing practices.

June 11, 2018 · DrugView details →

Class IIITerminated

ESTRADIOL 20mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-020-01

Qualgen, LLC

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

June 8, 2018 · DrugView details →

Class IITerminated

Irinotecan Hydrochloride Injection, USP, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-402-05.

Ingenus Pharmaceuticals Llc

Superpotent Drug: High out of specification assay value results for potency.

June 8, 2018 · DrugView details →

Class IIITerminated

TESTOSTERONE 200 mg PELLET, 1-count 3ml amber vial. RX only. Compounded by: Qualgen 14844 Bristol Park Blvd, Edmond OK 73013. NDC 69761-120-01

Qualgen, LLC

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

June 8, 2018 · DrugView details →

Class IITerminated

Irinotecan Hydrochloride Injection, USP, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial, Rx Only, Manufactured for: Ingenius Pharmaceuticals, LLC, Orlando, FL 32839-6408; Manufactured by: Ingenius Pharmaceuticals, GmbH Ticino 6917, Switzerland, NDC 50742-401-02.

Ingenus Pharmaceuticals Llc

Superpotent Drug: High out of specification assay value results for potency.

June 8, 2018 · DrugView details →

Class IIITerminated

Maxzide-25 (Triamterene and hydrochlorothiazide) tablets, USP, 37.5 mg/ 25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-0464-01

Mylan Pharmaceuticals Inc.

Superpotent Drug: Composite assay results obtained during routine stability testing were slightly above specification.

June 7, 2018 · DrugView details →

Class IITerminated

Kit for the Preparation of Technetium Tc99m Medronate, 20mg in 10 mL vial, packaged in a) 5-count box (NDC 45567-0040-1), b) 30-count box, NDC 45567-0040-2 , Rx only, Manufactured by: Pharmalucence, Inc., Billerica, MA 01821.

Pharmalucence, Inc.

Lack of assurance of sterility: Technetium TC-99M Medronate Kit has a reported breach of sterility.

June 6, 2018 · DrugView details →

Class IITerminated

HYDROmorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride, 1 mL Total Volume in 3 mL syringe, Rx, PharMEDium Services, LLC, Dayton, NJ

PharMEDium Services, LLC

Superpotent and Subpotent

June 5, 2018 · DrugView details →

Class ITerminated

Naloxone Hydrochloride Injection, USP, 0.4 mg/mL, 1 mL in 2.5 mL Carpuject Single-use cartridge syringe, Single unit (NDC 0409-1782-03) and 10 count box (NDC 0409-1782-69), Rx Only, Hospira Inc., Lake Forest, IL

HOSPIRA INC, LAKE FOREST

Presence of Particulate Matter; Potential for particulate matter on the syringe plunger.

June 4, 2018 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7983-02

ICU Medical Inc

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

May 31, 2018 · DrugView details →

Class IITerminated

5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7922-02

ICU Medical Inc

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

May 31, 2018 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only ,Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-37

ICU Medical Inc

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

May 31, 2018 · DrugView details →

Class IITerminated

Fluticasone propionate Nasal Spray, USP, 50 mcg, packaged in 50 mcg per spray 120 Metered Sprays bottles, 16 g net fill weight, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326, NDC 60505-0829-1

Apotex Inc.

Presence of foreign substance: glass particles

May 31, 2018 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7984-23

ICU Medical Inc

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

May 31, 2018 · DrugView details →

Class IITerminated

0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake Forest, IL 60045, NDC 0409-7730-37

ICU Medical Inc

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

May 31, 2018 · DrugView details →

Class IITerminated

Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-124-90 UPC 355111124900

Dr. Reddy's Laboratories, Inc.

Presence of Foreign Substance: A product complaint was received for a defective tablet with an embedded foreign object observed in a bottle.

May 30, 2018 · DrugView details →

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