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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, packaged in 100-count cartons of 10 trays x 10 unit dose cups, Major Pharmaceuticals, Livonia, MI 48152, NDC 0904-6846-73.

Plastikon Healthcare

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.

Aug 30, 2019 Other Drugs Nationwide View Details →

20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.

Compounded Solutions in Pharmacy

Class I - Dangerous

Lack of Processing Controls:

Sep 3, 2019 Other Drugs View Details →

Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharmacy 1515 Elizabeth St. Suite J Melbourne, FL 32901

Pacifico National, Inc.

Class I - Dangerous

Lack of assurance of sterility.

Aug 30, 2019 Prescription Drugs View Details →

5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles

Compounded Solutions in Pharmacy

Class I - Dangerous

Lack of Processing Controls:

Sep 3, 2019 Other Drugs View Details →

AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.

AVKARE

Class I - Dangerous

Failed Stability Specifications.

Aug 28, 2019 Prescription Drugs Nationwide View Details →

Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: Aurolife Pharma LLC Dayton NJ 08810 Manufactured for: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 65862-053-99

Aurobindo Pharma USA

Class I - Dangerous

Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B

Jul 29, 2019 Prescription Drugs Nationwide View Details →

RELPAX (eletriptan HBr) tablets, 40 mg, packaged in a) 6-count (1 card x 6 tablets) per carton, NDC 0049-2340-45; b) 12-count (2 cards x 6 tablets) per carton, NDC 0049-2340-05, Rx only, Made in Ireland, Distributed by Pfizer Roerig, Division of Pfizer Inc., NY, NY 10017.

Pfizer

Class I - Dangerous

Microbial Contamination of Non-Sterile Products: contamination with Burkholderia and Pseudomonas.

Aug 14, 2019 Prescription Drugs Nationwide View Details →

Vivitrol (naltrexone for extended-release injectable suspension) 380 mg/vial. Each Carton Contains: 1) One vial of 380 mg of Vivitrol, 2) One vial containing 4 mL of diluent, 3) One 5-mL prepackaged syringe, 4) One 20-gauge 1-inch needle, 5) Two 20-gauge 1.5-inch safety needles, 6) Two 20-gauge 2-inch safety needles. Rx Only. Manufactured and marketed by: Alkermes, Inc. Kit NDC: 65757-300-01

Alkermes

Class I - Dangerous

Labeling: Not Elsewhere Classified. Drug product kit recalled due to 1 inch needles being placed in the 1 1/2 inch needle cardboard sleeve labelled as administration needles. The product vial is not impacted.

Aug 8, 2019 Prescription Drugs Nationwide View Details →

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-903-90.

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Aug 6, 2019 Prescription Drugs Nationwide View Details →

Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 17478-902-10, b) 200 mg/100 mL (2 mg/mL), 100 mL Single-use Vial, NDC 17478-902-90, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045.

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Aug 6, 2019 Prescription Drugs Nationwide View Details →

Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, For Intravenous Use Only, Rx Only, Manufactured by: Akorn Inc., Lake Forest, IL 60045, NDC 17478-903-90.

Akorn

Class I - Dangerous

Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.

Aug 6, 2019 Prescription Drugs Nationwide View Details →

Clear Eyes Assorted IRC Display; each display contains 6 each of a) Clear eyes REDNESS RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.12%) eye drops, 0.5 FL OZ (15 mL) bottle (UPC 6 78112 25415 6); b) Clear eyes MAXIMUM REDNESS RELIEF (Glycerin 0.5%, Naphazoline hydrochloride 0.03%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 66577 8); and c) Clear eyes MAXIMUM ITCHY EYE RELIEF (Glycerin 0.25%, Naphazoline hydrochloride 0.012%, Zinc Sulfate 0.25%), 0.5 FL OZ (15 mL) bottle (UPC 6 78112 65920 3); Distributed by Medtech Products Inc., Tarrytown, NY 10591, A Prestige Brands Company, display UPC 6 78112 10452 9.

Medtech Products

Class I - Dangerous

CGMP Deviations: concerns regarding the sufficiency of Quality Assurance controls over critical systems in the manufacturing facility that could impact the product quality of the finished products.