December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged i
Hazard: Stability Data Does Not Support Expiry: lots do not have stability that supports the use of the container system.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin (2 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (200 mcg per mL), 10 mL Sterile single dose syringe, packaged
Hazard: Subpotent Drug: found to be below the specification for labeled assay.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin (1 mg/5 mL) 1 mg in 5% Dextrose Inj, USP QS 5 mL (200 mcg per mL), 5 mL Sterile single dose syringe, packa
Hazard: Subpotent Drug: found to be below the specification for labeled assay.
December 27, 2017DrugsFDA
Advanced Pharma Inc. recalls NitroGlycerin 1 mg/10 mL in 5% Dextrose Inj, USP QS 10mL (100 mcg per mL), 10 mL Sterile single dose syringe, packaged i
Hazard: Subpotent Drug: found to be below the specification for labeled assay.
December 27, 2017DrugsFDA
B. Braun Medical Inc recalls 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895
Hazard: Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
December 27, 2017DrugsFDA
Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC.
Hazard: Subpotent Drug
December 27, 2017DrugsFDA
Osmotica Pharmaceutical Corp recalls Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC
Hazard: Subpotent Drug
December 20, 2017DrugsFDA
Sun Pharmaceutical Industries, Inc. recalls Riomet (metformin hydrochloride) Oral Solution Cherry Flavored 500 mg /5 mL, 4 fl. oz. (NDC 10631-206-01) and 16 fl. oz.
Hazard: Microbial Contamination of Non-Sterile Products
December 20, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Penicillin V Potassium for Oral Solution, USP, 125 mg (200,000 U) per 5 mL, 100 mL (when mixed) bottle, Rx only, Manufac
Hazard: Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
December 13, 2017DrugsFDA
Elite Laboratories Inc. recalls Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 076
Hazard: Failed Impurities/Degradation Specifications
December 13, 2017DrugsFDA
Gadget Island, Inc recalls grande X 5800 capsule, (Maca Root 120 mg, Horny Goat Weed 120 mg, Guarana Seed 80 mg, Ginko Leaf 60 mg, Saw Palmetto 100
Hazard: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
December 13, 2017DrugsFDA
Gadget Island, Inc recalls FIFTY SHADES 6000 capsule, Proprietary Raw Material 4550, 1-capsule packets, distributed by Express Pac Trading, UPC 402
Hazard: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
December 13, 2017DrugsFDA
Gadget Island, Inc recalls PapaZen 3300 capsule, Proprietary Blend 1800mg, 1-capsule packets, distributed by FX Power San Diego, CA 92108, UPC 7181
Hazard: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
December 13, 2017DrugsFDA
Gadget Island, Inc recalls RHINO 7 Platinum 5000, capsule, Proprietary Material: 750mg, 1-capsule packets, distributed by Fifty Shades Bayside, NY
Hazard: Marketed without an Approved NDA/ANDA: undeclared Active Pharmaceutical Ingredients sildenafil, desmethyl carbodenafil and tadalafil.
December 13, 2017DrugsFDA
International Laboratories, Inc. recalls Pravastatin Sodium Tablets, USP, 40 mg, 30-count bottle, Rx only, Packaged for: International Laboratories, LLC. St. Pet
Hazard: Labeling: Label mix-up, the product labeled as Pravastatin sodium tablets 40 mg was filled with Bupropion hydrochloride XL Tablets 300 mg.
December 6, 2017DrugsFDA
Zydus Pharmaceuticals USA Inc recalls Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count (NDC 68382-099-05), and c) 1000 count (NDC
Hazard: Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets
December 6, 2017DrugsFDA
EAI-JR286 INC recalls Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titanium Dioxide 6.3%, Zinc Oxide 9.9%) Sun Prote
Hazard: CGMP Deviations: products manufactured in a manner that may impact product quality that includes but is not limited to failed viscosity.
December 6, 2017DrugsFDA
Hetero Labs, Ltd. - Unit III recalls Levetiracetam Oral Solution, USP, 100 mg/mL, packaged in a 16 fl oz (473 mL) bottle, Rx only, Manufactured for: Camber P
Hazard: Presence of foreign substance (screw)
December 6, 2017DrugsFDA
Mayne Pharma Inc recalls Liothyronine Sodium Tablets, USP 25 mcg ,100-count bottles, Rx Only, Distributed by Perrigo Minneapolis, MN 55427, NDC
Hazard: Failed Dissolution Specifications.
December 6, 2017DrugsFDA
Lupin Pharmaceuticals Inc. recalls Duloxetine Delayed-Release Capsules USP, 30 mg, 30-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.
Hazard: Failed Dissolution Specification
December 6, 2017DrugsFDA
Teva Pharmaceuticals USA recalls Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jer
Hazard: Failed Tablet/Capsule Specifications; potential presence of broken tablets.
December 6, 2017DrugsFDA
NEW RELIANCE TRADING, INC. recalls No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers (Pak), Gujranwala, Distributed by NEW RELIANCE TRADING, INC., 5
Hazard: Marketed Without an Approved NDA/ANDA
November 29, 2017DrugsFDA
West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 20 mg/5 mL (4 mg/mL), 5 mL Vials (NDC 0641-6146-01), packaged in 25 x 5 m
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
November 29, 2017DrugsFDA
West-Ward Pharmaceuticals Corp. recalls Dexamethasone Sodium Phosphate Injection, USP, 4 mg/mL, 1 mL Vials (NDC 0641-6145-01), packaged in 25 x 1 mL Vials per s
Hazard: Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
November 29, 2017DrugsFDA
Lupin Limited recalls Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimo
Hazard: Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy complaint where one Duloxetine Delayed Release Capsule, 30mg was found in a Pravastatin Sodium Tablets USP, 40mg bottle.
November 29, 2017DrugsFDA
Amerisource Health Services recalls Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohi
Hazard: Presence of Foreign Tablets/Capsules.
November 29, 2017DrugsFDA
Ridge Properties, LLC recalls Extra Strength Naturally HL Hemorrhoid Numbing with Lidocaine, (lidocaine HCL 4%), 1/2 oz Balm (NDC 69804-014-06), and 2
Hazard: GMP Deviations: inadequate manufacturing control processes
November 29, 2017DrugsFDA
Ridge Properties, LLC recalls Extra Strength Naturally HL Liquid Hemorrhoid Relief Gel, (lidocaine HCL 4%), 1/2 oz Liquid Gel (NDC 69804-024-13), 1 o
Hazard: GMP Deviations: inadequate manufacturing control processes
November 29, 2017DrugsFDA
Ridge Properties, LLC recalls Extra Strength Naturally HL Hemorrhoid Numbing Spray with Lidocaine, (lidocaine HCL 4%), 1/2 oz Spray (NDC 69804-015-08)
Hazard: GMP Deviations: inadequate manufacturing control processes
November 29, 2017DrugsFDA
Ridge Properties, LLC recalls Extra Strength PreTAT by TAT BALM Gel, (lidocaine HCL 4%), 1/2 oz Gel (NDC 69804-018-09), 1 oz Gel (NDC 69804-018-10) ,
Hazard: GMP Deviations: inadequate manufacturing control processes