January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx on
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
January 31, 2018DrugsFDA
Marksans Pharma Inc. recalls Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for
Hazard: CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
January 31, 2018DrugsFDA
International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing
Hazard: Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
January 31, 2018DrugsFDA
International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing
Hazard: Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle.
January 31, 2018DrugsFDA
Odan Laboratories Ltd recalls Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml /
Hazard: Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
January 31, 2018DrugsFDA
Odan Laboratories Ltd recalls Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Ca
Hazard: Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
January 31, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls bupPROPion HCL Extended-Release Tablets, USP (XL) 300 mg, 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morganto
Hazard: Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
January 31, 2018DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmace
Hazard: Lack Of Assurance Of Sterility
January 24, 2018DrugsFDA
Unichem Pharmaceuticals Usa Inc recalls Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories
Hazard: Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
January 24, 2018DrugsFDA
Pharmatech LLC recalls Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120 mL) plastic bottles, Distributed by: Rugby
Hazard: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
January 24, 2018DrugsFDA
Pharmatech LLC recalls Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl oz (237 mL) plastic bottles, Distributed by:
Hazard: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
January 24, 2018DrugsFDA
Pharmatech LLC recalls Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by: R
Hazard: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
January 24, 2018DrugsFDA
Pharmatech LLC recalls Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:
Hazard: Microbial Contamination of Non Sterile Product; presence of yeast and potential B. cepacia contamination
January 24, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,
Hazard: Presence of foreign substance: metallic razor blade was found in one bottle.
January 24, 2018DrugsFDA
AVKARE Inc. recalls Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38
Hazard: Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing.
January 24, 2018DrugsFDA
Pharmedium Services, LLC recalls Phenylephrine HCL 100 mcg per mL (1 mg/10 mL) in 0.9% Sodium Chloride 10 mL syringes, PharMEDium Services, LLC 913 N Da
Hazard: Superpotent Drug
January 24, 2018DrugsFDA
Pharmedium Services, LLC recalls ePHEDrine Sulfate In 0.9% Sodium Chloride, 5 mg per mL (50 mg per 10 mL), 10 mL Total Volume pre-filled syringes, packag
Hazard: Subpotent Drug
January 24, 2018DrugsFDA
Shionogi Inc. recalls Mefenamic Acid Capsules, USP, 250 mg, 30-count bottle, Rx only, Distributed by Prasco Laboratories, Mason, OH 45040, Man
Hazard: Presence of foreign substance: The recall was initiated due to black particles being observed while performing routine post-release stability testing on Mefenamic acid capsules
January 24, 2018DrugsFDA
SHISEIDO AMERICA INC. recalls Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% an
Hazard: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
January 24, 2018DrugsFDA
SHISEIDO AMERICA INC. recalls Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzo
Hazard: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
January 24, 2018DrugsFDA
SHISEIDO AMERICA INC. recalls Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc
Hazard: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
January 24, 2018DrugsFDA
SHISEIDO AMERICA INC. recalls Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide
Hazard: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
January 24, 2018DrugsFDA
SHISEIDO AMERICA INC. recalls bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottl
Hazard: GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
January 17, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Docetaxel Injection USP, 20 mg/mL, One-Vial Formulation, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatn
Hazard: Defective Container: Product complaints received of defect in the seal of the Docetaxel injection vials that the aluminum seal and/or stopper is removed when the cap is flipped off.
January 17, 2018DrugsFDA
Pfizer Manufacturing Deutschland GmbH recalls FOR EXPORT ONLY Atorvastatin calcium Film-Coated Tablets a) 80 mg SMT Tabs Bulk, b) 40 mg SMT G EP PR KR, c) 20 mg SMT G
Hazard: Microbial Contamination of Non-Sterile Products
January 17, 2018DrugsFDA
Akorn Inc recalls Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Ph
Hazard: CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
January 17, 2018DrugsFDA
Woodfield Pharmaceutical, LLC recalls Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmace
Hazard: Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
January 17, 2018DrugsFDA
Prinston Pharmaceutical Inc recalls Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xun
Hazard: Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle.