October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratorie
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratori
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laborator
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-05
Hazard: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
October 31, 2018DrugsFDA
Pfizer Inc. recalls Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc.
Hazard: Lack of assurance of sterility: loss of container integrity.
October 31, 2018DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawad
Hazard: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
October 31, 2018DrugsFDA
RemedyRepack Inc. recalls Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30
Hazard: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
October 31, 2018DrugsFDA
LUPIN SOMERSET recalls Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore,
Hazard: Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
October 31, 2018DrugsFDA
Westlab Pharmacy, Inc. dba Westlab Pharmacy recalls Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92
Hazard: Lack of Process Controls
October 31, 2018DrugsFDA
Westlab Pharmacy, Inc. dba Westlab Pharmacy recalls ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorol
Hazard: Lack of Process Controls
October 31, 2018DrugsFDA
Westlab Pharmacy, Inc. dba Westlab Pharmacy recalls Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00
Hazard: Incorrect Product Formulation
October 31, 2018DrugsFDA
Lupin Pharmaceuticals Inc. recalls Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimor
Hazard: Defective Container: Repetitive complaints received indicating pump not working.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant P
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
October 31, 2018DrugsFDA
Valeant Pharmaceuticals North America LLC recalls Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant
Hazard: CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident.
October 31, 2018DrugsFDA
Lannett Company, Inc. recalls HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by
Hazard: CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
October 24, 2018DrugsFDA
Amerigen Pharmaceuticals Inc. recalls Temozolomide capsules, 20 mg, packaged in a) 5-count bottle(NCD 43975-253-05), b) 14-count bottle (NDC 43975-253-14), Rx
Hazard: Failed dissolution specifications: Out-of-Specification dissolution results obtained during stability testing.
October 24, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Clonazepam Orally Disintegrating Tablets USP, 2 mg., 60-count carton. RX only. Teva Pharmaceuticals USA, INC. North Whal
Hazard: Failed Stability Specifications: Out-of-specification test result for water content obtained during routine stability testing.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Family Dollar Saline Nasal Spray 4.25 oz. can, 24 pk, SKU 0900562.
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Finafta Baby, Oral Gel (benzocaine 7.5%), 7.1 Grams (0.25 Oz.) tube, Distributed By: Efficient Laboratories, Inc., Miami
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48/3/1 #12687
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rexall, Sinus Nasal Pump Mist, (Oxymetazoline Hydrochloride 0.05%), 1 FL OZ (30mL) bottle, SKU 00744201
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rhinall Nasal Decongestant Nasal Spray (phenylephrine HCl), 0.25%, 1 1/3 Fl Oz. (40 ml), Manufactured for: Scherer Labor
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Sinus Relief (oxymetazoline HCl) Nasal decongestant, 0.05%, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc.
Hazard: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Pseudomonas aeruginosa.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Original Strength, Triple Antibiotic Ointment Spray (bacitracin zinc 400 units, neomycin sulfate 3.5 mg, pol
Hazard: Subpotent Drug: low out of specification assay results for the bacitracin zinc ingredient.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Mushatt's No. 9, PsoriWash Medicated Wash, Salicylic Acid 1.8%, 8 oz. (226 g) tube, Distributed by Mushatts, LLC, P.O. B
Hazard: Microbial Contamination of Non-Sterile Products and Subpotent Drug: failure for microbiological growth exceeding specification and low out of specification assay results for salicylic acid.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CeraVe Healing Lip Balm/SPF 30 (avobenzone 3%, dimethicone 1%, homosalate 10%, octisalate 5%, octocrylene 10%, Net Wt. 0
Hazard: Microbial Contamination of Non-Sterile Products: Failed microbiological testing for Staphalococcus aureus.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Cicatricure, Scar Cream + Sunscreen SPF 30 (avobenzone 3%, octocrylene 10%, oxybenzone 6%), 0.7 oz. (19.8 g) tube, Distr
Hazard: Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.