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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Potassium Phosphates Inj., USP, 45 mM (3 mM P/mL) Also contains: 66 mEq K+ (4.4 mEq/mL) 15 mL, Single-dose, Caution: Must Be Diluted, Rx Only, Mfd by Hospira, Inc. Lake Forest, IL 60045 USA, NDC: 0409-7295-01

Hospira a Pfizer Company

Class I - Dangerous

Lack of Sterility Assurance

Jun 15, 2017 Prescription Drugs View Details →

Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30

PD-Rx Pharmaceuticals

Class I - Dangerous

Failed Tablet/Capsule Specification: out of specification for tablet weight.

Jul 28, 2017 Prescription Drugs Nationwide View Details →

Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50

VistaPharm

Class I - Dangerous

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Jun 26, 2017 Other Drugs View Details →

Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric Acid) Effervescent Tablets, 24-count carton, Made in Germany, Distributed by Bayer HealthCare, LLC Whippany, NJ 07981, UPC 016500044048

Bayer HealthCare Pharmaceuticals

Class I - Dangerous

Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.

Mar 30, 2017 Prescription Drugs Nationwide View Details →

Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68382-032-05),Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Zydus Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications

May 10, 2017 Prescription Drugs Nationwide View Details →

Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carton (NDC 0409-6609-25), Rx Only, Mfd by Hospira, INC, Lake Forest, IL 60045 USA

Hospira a Pfizer Company

Class I - Dangerous

Lack of Sterility Assurance

Jun 15, 2017 Prescription Drugs View Details →

Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054, NDC 68382-031-01

Zydus Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications

May 10, 2017 Prescription Drugs Nationwide View Details →

Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC 55111-229-05), Rx only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA; Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 USA.

Dr. Reddy's Laboratories

Class I - Dangerous

Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.

Jul 11, 2017 Prescription Drugs Nationwide View Details →

Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080, NDC 68094-301-59.

Precision Dose

Class I - Dangerous

Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.

Jul 5, 2017 Prescription Drugs View Details →

Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025

Fusion IV Pharmaceuticals, Inc.

Class I - Dangerous

CGMP Deviations

Jul 12, 2017 Prescription Drugs View Details →

Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (NDC 68382-033-05), Rx only, manufactured by Cadila Healthcare Ltd, Ahmedabad, India, Distributed by: Zydus Pharmaceuticals, Pennington, NJ 07054

Zydus Pharmaceuticals USA

Class I - Dangerous

Failed Dissolution Specifications

May 10, 2017 Prescription Drugs Nationwide View Details →

Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA --- NDC 0172-5728-60

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Tablet/Capsule Specification; out of specification for tablet weight

Jul 24, 2017 Prescription Drugs Nationwide View Details →

Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.) one vial (NDC: 0409-6629-02), b.) 25 vial carton (NDC: 0409-6629-25).

Hospira a Pfizer Company

Class I - Dangerous

Lack of Sterility Assurance

Jun 15, 2017 Prescription Drugs View Details →

Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01

VistaPharm

Class I - Dangerous

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Jun 26, 2017 Other Drugs View Details →

Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials For Inhalation per carton, Rx only, Mfd. for: Watson Laboratories, Inc., Corona, CA 92880; Mfd. by: Cipla Ltd., Verna, Goa INDIA, NDC 0591-3467-53.

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurities/Degradation Specifications: high out of specification results for related compound D.

Jul 25, 2017 Prescription Drugs Nationwide View Details →

Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pulaski, TN 38478 --- NDC: 50268-0190-15

Apace KY

Class I - Dangerous

Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg

Jun 19, 2017 Prescription Drugs View Details →

PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0812-40

SCA Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility; product has the potential to leak.

Jul 14, 2017 Prescription Drugs Nationwide View Details →

PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0809-40

SCA Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility; product has the potential to leak.

Jul 14, 2017 Prescription Drugs Nationwide View Details →

PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0816-40

SCA Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility; product has the potential to leak.

Jul 14, 2017 Prescription Drugs Nationwide View Details →

fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC# 70004-0202-40

SCA Pharmaceuticals

Class I - Dangerous

Lack of Assurance of Sterility; product has the potential to leak.

Jul 14, 2017 Prescription Drugs Nationwide View Details →