December 26, 2018DrugsFDA
CBI Laboratories, Inc. recalls Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%, Octisalate 5%, Oxybenzone 6%), 4.5 Oz/127.5 g tube.
Hazard: Subpotent Drug:Out of specification for percentage of active pharmaceutical ingredients.
December 26, 2018DrugsFDA
KVK-Tech, Inc. recalls Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702
Hazard: Labeling: Wrong bar code
December 26, 2018DrugsFDA
Pfizer Inc. recalls Levoxyl (levothyroxine sodium tablets, USP) tablets 112 mcg, 100-count bottle, Rx Only,Distributed by Pfizer Inc. New Y
Hazard: Superpotent Drug.
December 26, 2018DrugsFDA
Gordon Laboratories recalls Monsel's (Ferric Subsulfate) Solution, 8 mL amber glass bottle, packaged as one dozen bottles with applicators per box,
Hazard: Superpotent Drug: contains higher levels of Iron than labeled.
December 26, 2018DrugsFDA
Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye Free, Non-staining Berr
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
December 26, 2018DrugsFDA
Tris Pharma Inc. recalls Infants' Ibuprofen, Concentrated Ibuprofen Oral Suspension, USP, (NSAID), 50 mg per 1.25 mL, Dye-Free Non-Staining Berry
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
December 26, 2018DrugsFDA
Tris Pharma Inc. recalls infants* IBUPROFEN, Concentrated Ibuprofen Oral Suspension, USP (NSAID), 50 mg per 1.25 mL, Dye-Free Berry Flavor, 0.5 F
Hazard: Superpotent Drug: recalled lots may have higher concentration of ibuprofen.
December 26, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate 2 mcg per mL (200 mcg per 100 mL) and Ropivacaine HCl 0.2% in Sodium Chloride 0.9%, Injection, 100 mL t
Hazard: Sub-potent
December 26, 2018DrugsFDA
Pharmedium Services, LLC recalls Fentanyl Citrate 2 mcg per mL (100 mcg per 50 mL) and Ropivacaine HCl 0.1% in Sodium Chloride 0.9%, Injection, 50 mL tot
Hazard: Sub-potent
December 26, 2018DrugsFDA
GE Healthcare Inc. Life Sciences recalls Omnipaque (iohexol) Injection, 180mgI/mL, 20 mL Single-Dose Vial, packaged in 10 x 20 mL Vials per carton, Rx only, Dist
Hazard: Defective Container: vial defect was identified that could potentially impact the container closure and result in a lack of sterility assurance and/or the potential for glass particles.
December 26, 2018DrugsFDA
Epic Pharma, LLC recalls Estradiol Tablets, USP, 2 mg, 100-count bottle, Rx Only, Distributed by: Epic Pharma, LLC Laurelton, NY 11413, NDC 42806
Hazard: Presence of foreign tablet/capsule: A single foreign tablet was found in pharmacy dispensed bottle of 30 Estradiol 2 mg tablets.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 320/25 mg, (a) 90-count bottle (NDC 0378-6325-77), (b) 500-count bottles
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottle
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 160/12.5 mg, (a) 90-count bottle (NDC 0378-6322-77), (b) 500-count bottle
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan Tablets, USP 320 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan Tablets, USP 160 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan Tablets, USP 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., M
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan Tablets, USP 40 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., M
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Amlodipine and Valsartan Tablets, USP 10/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Amlodipine and Valsartan Tablets, USP 5/320 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharma
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Amlodipine and Valsartan Tablets, USP 10/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Laboratories Limited, (Nashik FDF) recalls Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharm
Hazard: GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Amlodipine and Valsartan Tablets, USP, 10 mg/320 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Ph
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 320 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 40 mg, 30-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., M
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 160 mg, 90-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.
December 19, 2018DrugsFDA
Mylan Pharmaceuticals Inc. recalls Valsartan Tablets, USP, 80 mg, 90-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc.,
Hazard: CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.