September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count cartons, DISCOUNT drug mart FOOD FAIR, Distributed by
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Wal-Fex (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 5-count cartons, Distributed By: Walgreen Co., 200 Wilmot Rd.,
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Allergy (Fexofenadine Hydrochloride) Tablets USP, 180 mg, 30-count bottles, Distributed by: Aurohealth LLC, 2572 Brunswi
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Fexofenadine HCL Tablets USP, 180 mg, 500's BRITE STOCK; Manufactured for: Aurohealth LLC., 2572 Brunswick Pike, Lawrenc
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 62011-0315-1); and b) 30-count cart
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Allergy Relief (Fexofenadine HCl) tablets USP, 180 mg, 15-count cartons, equate, Distributed by: Wal-Mart Stores, Inc.,
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Fexofenadine Hydrochloride Tablets USP, 180 mg, packaged in a) 30-count carton (NDC 70677-0008-2) and b) 15-count carton
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls fexofenadine hydrochloride tablets USP, 180 mg, 150-count bottle, Member's Mark, Distributed by: Sam's West, Inc., Bento
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Allergy Relief (fexofenadine hydrochrloride) tablets, 180 mg, 5-count carton, Good Neighbor Pharmacy, Distributed By Ame
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Allergy Relief (Fexofenadine Hydrochrloride) Tablets USP, 180 mg, packaged in a) 15-count cartons (NDC 60000-409-53); b)
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
Aurolife Pharma, LLC recalls Fexofenadine Hydrochrloride Tablets USP, 180 mg, 100-count bottle, Distributed by: Aurohealth LLC., 2572 Brunswick Pike,
Hazard: Failed Impurities/Degradation Specifications
September 25, 2019DrugsFDA
West-Ward Columbus Inc recalls Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatont
Hazard: Failed Impurities/Degradation Specificattion
September 25, 2019DrugsFDA
Torrent Pharma Inc. recalls Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in India for: Torrent Pharma Inc., Basking Ri
Hazard: Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls Soothing Sore Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-077-14), b) 2 Oz (NDC 69804-077-15), an
Hazard: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls Soothing Sore Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-074-05), b) 2 OZ (NDC 69804-074-02), and c) 4
Hazard: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls Superior Pain & Itch Relief (lidocaine) Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-073-14), b) 2 Oz (NDC 69804-073-1
Hazard: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls Superior Pain & Itch Relief (lidocaine) Cream, 4%, packaged in a) 1 OZ (NDC 69804-070-05), b) 2 OZ (NDC 69804-070-02), a
Hazard: Superpotent Drug: products were found to be contaminated and above specification for lidocaine assay.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Liquid Gel, 4%, packaged in a) 1 Oz (NDC 69804-019-14), b) 2 O
Hazard: Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
September 25, 2019DrugsFDA
Ridge Properties, LLC recalls PRE-TAT (lidocaine) 3 in 1 Pre Tattoo Prep With Lidocaine Cream, 4%, packaged in a) 1 OZ (NDC 69804-002-05), b) 2 OZ (ND
Hazard: Microbial Contamination of Non-Sterile Products: products were found to be contaminated and above specification for lidocaine assay.
September 18, 2019DrugsFDA
Plastikon Healthcare LLC recalls Milk of Magnesia USP, 2400 mg/30 mL, Magnesium Hydroxide 2400 mg, 30 mL unit dose cups, For Institutional Use Only, pack
Hazard: Microbial Contamination of Non-Sterile Products: product failed bioburden testing for Total Aerobic Microbial Count.
September 18, 2019DrugsFDA
AVKARE Inc. recalls AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.
Hazard: Failed Stability Specifications.
September 18, 2019DrugsFDA
Compounded Solutions in Pharmacy recalls 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml dropper bottles
Hazard: Lack of Processing Controls:
September 18, 2019DrugsFDA
Compounded Solutions in Pharmacy recalls 10% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml, b) 10ml c) 15 ml, dropper bottles
Hazard: Lack of Processing Controls:
September 18, 2019DrugsFDA
Compounded Solutions in Pharmacy recalls 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle.
Hazard: Lack of Processing Controls:
September 18, 2019DrugsFDA
Pfizer Inc. recalls Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hospira, Inc., Lake Forest, IL 60045 USA. NDC
Hazard: Lack of Assurance of Sterility
September 18, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plain
Hazard: Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
September 18, 2019DrugsFDA
Pacifico National, Inc. dba AmEx Pharmacy recalls Bevacizumab, 1.25 mg/0.05 mL, 31G MJ Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharma
Hazard: Lack of assurance of sterility.
September 18, 2019DrugsFDA
Pacifico National, Inc. dba AmEx Pharmacy recalls Bevacizumab, 2.5 mg/0.1 mL, Norm-Ject Syringe Intravitreal Injection, Single use only, Rx only, Repackaged by AmEx Pharm
Hazard: Lack of assurance of sterility.
September 18, 2019DrugsFDA
Mylan Pharmaceuticals Inc. recalls Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: Mylan Pharmaceuticals Inc., Morgantown, WV
Hazard: Failed Impurities/Degradation Specifications:OOS for unknown impurity.
September 18, 2019DrugsFDA
American Health Packaging recalls Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, NDC 60687-362-21 (Individual Dose NDC: 60687
Hazard: Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths section of the insert that incorrectly lists the tablet description coding for the tablets.