October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Harmon Face Values, Saline Nasal Gel with Soothing Aloe, 0.5 oz. (14.1 g) tube, Distributed by: Harmon Stores, Inc., Uni
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls FAMILY wellness, Sterile Saline, Nasal Mist, Saline Nasal Relief (0.9% Sodium Chloride Solution), 4.25 FL OZ (126 mL) ca
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls DG health, No Drip, Nasal Pump Mist (oxymetazoline hydrochloride), 0.05%, 1 FL OZ (30 mL) bottle, Distributed by: Dolgen
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Discount Drug Mart, Food Fair, Saline Nasal Spray (sodium chloride) 0.65%, packaged as a) 3 FL OZ (89 mL) bottle UPC 0 9
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Saline Nasal Spray, 1.5 FL OZ bottle, Distributed by CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895,
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Saline Nasal Gel with Soothing Aloe, packaged as a) Baby Net Wt. 0.5 OZ (14.2 g) tube UPC 0 50428 58392 0 Pr
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Baby Nasal Spray/Drops, Non-Medicated, 0.5 FL OZ (15 mL) bottle, Distributed by: CVS Pharmacy, Inc., One CVS
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Sterile Saline Nasal Mist (sodium chloride) Allergy & Sinus Relief, 3.0%, 4.25 OZ (126 g) can, Distributed b
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Saline Nasal Spray, Nasal Moisturizing Spray, Contains: Sodium Chloride 0.65%, Benzyl Alcohol & Benzalkonium
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CVS Health, Sterile Saline Nasal Mist (sodium chloride) Saline Nasal Moisturizer, 0.9%, packaged in a) Net Wt. 1.52 OZ (
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls CareOne, Saline Nasal Gel With Soothing Aloe, Net Wt. 0.5 OZ (14.1 g) tube, Distributed by Foodhold U.S.A., LLC., Landov
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls Rhinall (phenylephrine hydrochloride) Nasal Decongestant Nose Drops, 0.25%, 1 FL OZ (30 mL) bottle, Distributed by: Sche
Hazard: CGMP Deviations: products manufactured under conditions that could impact its product quality.
October 24, 2018DrugsFDA
Product Quest Manufacturing LLC recalls DERMATONE (titanium oxide 6% and zinc oxide 4.7%) No-Touch Sunscreen Stick, SPF 50, Net Wt. 0.49 oz. (13.9g) stick, Dist
Hazard: Microbial Contamination of Non-Sterile Products: sample tested positive for Staphylococcus aureus.
October 24, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91
Hazard: Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
October 24, 2018DrugsFDA
Humco Holding Group, Inc recalls Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 24, 2018DrugsFDA
Humco Holding Group, Inc recalls Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 24, 2018DrugsFDA
Humco Holding Group, Inc recalls Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 17, 2018DrugsFDA
GLAXOSMITHKLINE NEBRASKA recalls Prevacid 24HR (Lansoprazole) delayed-release capsules, 15 mg, 14 capsules per bottle in a carton containing 1 bottle (ND
Hazard: CGMP deviations
October 17, 2018DrugsFDA
Takeda Development Center Americas, Inc. recalls Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Di
Hazard: Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets.
October 17, 2018DrugsFDA
Xiromed LLC recalls Altavera Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg and 0.03 mg, Rx only, 3 tablet dispensers x 28 tablet
Hazard: Labeling: Not Elsewhere Classified: mislabeling of the Altavera generic name on the packaging component that may cause confusion.
October 17, 2018DrugsFDA
Pfizer Inc. recalls Magnesium Sulfate in Water for Injection (0.325 mEq Mg++/mL) 40 mg/mL, 20 g Total, 500 mL Single-Dose Container bag, Rx
Hazard: Correct Labeled Product Mispack: confirmed report involving a single unit of properly labeled Heparin in 0.45% Sodium Chloride for Injection (NDC 0409-7651-03, Lot 87903FW) that was found inside a case of Magnesium Sulfate in Water for Injection.
October 17, 2018DrugsFDA
Syntec Pharma Corp recalls THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labe
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 17, 2018DrugsFDA
Syntec Pharma Corp recalls THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothy
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 17, 2018DrugsFDA
InvaGen Pharmaceuticals, Inc. recalls Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manuf
Hazard: Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
October 17, 2018DrugsFDA
Jubilant Cadista Pharmaceuticals, Inc. recalls Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics L
Hazard: Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
October 17, 2018DrugsFDA
Pfizer Inc. recalls Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapac
Hazard: CGMP Deviations; rejected product was used to manufacture final bulk lot
October 17, 2018DrugsFDA
Alkano Chemicals, Inc recalls Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia
Hazard: CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
October 10, 2018DrugsFDA
Otsuka Pharmaceutical Development & Commercialization, Inc. recalls treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit
Hazard: Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
October 10, 2018DrugsFDA
Otsuka Pharmaceutical Development & Commercialization, Inc. recalls treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Ki
Hazard: Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
October 10, 2018DrugsFDA
Endo Pharmaceuticals, Inc. recalls robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc.,
Hazard: Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."