August 9, 2017DrugsFDA
VistaPharm, Inc. recalls Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by Vi
Hazard: Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Gold (1000 mg Anhydrous citric acid, 344 mg Antacid Potassium bicarbonate, 1050 mg Antacid Sodium bicarbon
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Extra Strength (500 mg Aspirin (NSAID), 1985 mg Analgesic Sodium bicarbonate/Antacid, 1000 mg Anhydrous Cit
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
August 9, 2017DrugsFDA
Hospira a Pfizer Company recalls Neut Sodium Bicarbonate 4% (2.4 mEq) Additive Solution 5 mL , a.) Single-dose vial (NDC 0409-6609-02), b.) 25 vial carto
Hazard: Lack of Sterility Assurance
August 9, 2017DrugsFDA
Hospira a Pfizer Company recalls Succinylcholine Chloride Injection, USP 200 mg (20 mg/mL) Quelicin Multiple-dose vial, 10 mL, For I.V. or I.M. use. a.
Hazard: Lack of Sterility Assurance
August 9, 2017DrugsFDA
Hospira a Pfizer Company recalls 8.4% Sodium Bicarbonate Inj., USP 50 mL Single-dose, 50 mEq (1 mEq/mL) 4.2 grams (84 mg/mL), Rx Only, Mfd by Hospira, I
Hazard: Lack of Sterility Assurance
August 9, 2017DrugsFDA
Hospira a Pfizer Company 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: Mus
Hazard: Lack of Sterility Assurance
August 9, 2017DrugsFDA
Bayer HealthCare Pharmaceuticals, Inc. recalls Alka-Seltzer Original ( 325 mg Aspirin (NSAID), 1916 mg Analgesic, Sodium bicarbonate/Antacid, 1000 mg Anhydrous Citric
Hazard: Defective Container: Confirmed customer compliant of small holes or cracks in the foil of blister packs.
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 500 mg, a.) 100-count bottle (NDC 68382-033-01) b.) 500-count bottle (ND
Hazard: Failed Dissolution Specifications
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 250 mg 100-count bottle (NDC 68382-032-01), b.) 500-count bottle (NDC 68
Hazard: Failed Dissolution Specifications
August 9, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Divalproex Sodium Delayed Release Tablets, USP, 125 mg, 100-count bottle Rx only, Manufactured by Cadila Healthcare Ltd
Hazard: Failed Dissolution Specifications
August 9, 2017DrugsFDA
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical recalls Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmace
Hazard: CGMP Deviations
August 9, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Albuterol Sulfate Inhalation Solution, 0.021% (0.63 mg/3mL), packaged in 5 pouches of 5 x 3mL Sterile Unit-Dose Vials Fo
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for related compound D.
August 9, 2017DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, packaged in a) 90-count bottles (NDC 55111-229-90) and b) 500-count bottles (NDC
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for related impurity for lot C700220.
August 9, 2017DrugsFDA
Precision Dose Inc. recalls Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL
Hazard: Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
August 9, 2017DrugsFDA
Apace KY LLC recalls Cyclobenzaprine HCl Tablets, USP, 5 mg, 50 Tablets (5x10) Unit Dose Cartons, Rx Only, Manufactured for: AvKARE Inc, Pula
Hazard: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
August 9, 2017DrugsFDA
Apace KY LLC recalls Amantadine HCl Capsules, USP, 100 mg, Rx Only, 50 Capsules (5x10) Unit Dose Cartons, Manufactured for: AvKARE Inc, Pula
Hazard: Labeling; Label Mix up; cartons labeled as Amantadine HCl 100 mg Capsules contain unit dose blister cards of Cyclobenzaprine HCl Tablet, USP 5 mg
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock,
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock,
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 20 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 -
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmaceuticals 882PHENYLephrine 100 mg 1 Knoedl C
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free, Rx only, SCA Pharmaceuticals 8821 Knoedl
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls PHENYLephrine HCl 60 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 7220
Hazard: Lack of Assurance of Sterility; product has the potential to leak.
August 2, 2017DrugsFDA
SCA Pharmaceuticals recalls NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct L
Hazard: Lack of Assurance of Sterility; product has the potential to leak.