October 10, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44)
Hazard: Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
October 10, 2018DrugsFDA
Sichuan Friendly Pharmaceutical Co.,Ltd. recalls Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongp
Hazard: CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 10, 2018DrugsFDA
Pfizer Inc. recalls Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Divisi
Hazard: Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
October 10, 2018DrugsFDA
BioLyte Laboratories, LLC recalls NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.
Hazard: CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
October 10, 2018DrugsFDA
Teva Pharmaceuticals USA recalls Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wale
Hazard: Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
October 3, 2018DrugsFDA
Boehringer Ingelheim Pharmaceuticals, Inc. recalls Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: B
Hazard: Cross Contamination With Other Products:
October 3, 2018DrugsFDA
Baxter Healthcare Corporation recalls Levofloxacin Injection in 5% Dextrose, 5 mg/mL, packaged in a) 50 mL (NDC 36000-046-24), b) 100 mL (NDC 36000-047-24), c
Hazard: Superpotent Drug: High out of specification results for levofloxacin resulting in increased concentration of solution.
October 3, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadc
Hazard: Discoloration: A complaint was received from a pharmacist for the presence of blue specks on tablets.
October 3, 2018DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Fenofibrate Tablets, USP 145 mg, 90-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, N
Hazard: Presence of Foreign Tablet/Capsule: A foreign identified as Valacyclovir tablet 500 mg was co-mingled in a bottle containing Fenofibrate Tablets, USP 145 mg.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmace
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmace
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by:
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Noven Pharmaceuticals, Inc. recalls Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. b
Hazard: Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches.
October 3, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma
Hazard: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
October 3, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection, 5mg/100 mL (0.05 mg/mL) 100ml vial, Rx Only. Mfd By: Gland Pharma Limited D.P. Pally - 500 04
Hazard: Failed Impurities/Degradation Specifications: OOS for unknown impurities.
October 3, 2018DrugsFDA
Hetero Labs Limited Unit V recalls Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla
Hazard: Labeling: Label Mix-Up - One lot labeled Montelukast Sodium Tablets 10 mg tablets may contain 90 tablets of Losartan Potassium 50 mg.
September 26, 2018DrugsFDA
LUPIN SOMERSET recalls Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. S
Hazard: Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing.
September 26, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cip
Hazard: Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
September 26, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury,
Hazard: Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
September 26, 2018DrugsFDA
Torrent Pharma Inc. recalls Lamotrigine Extended-Release Tablets, USP, 200 mg, 30 tablets per bottle, Rx Only, Manufactured in INDIA, For: TORRENT P
Hazard: Failed Dissolution Specifications: Out of Specification for Dissolution test (Buffer Stage) at the 5-hour time point during stability testing.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumon
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Be
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Be
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bi
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distribute
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-M
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Beaumont Bio-med, Inc. recalls Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed
Hazard: CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination.
September 26, 2018DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532
Hazard: Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets .
September 26, 2018DrugsFDA
Baxter Healthcare Corporation recalls 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338
Hazard: cGMP Deviation