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Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

Valsartan Tablets USP 160 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-572-90

Aurobindo Pharma USA

Class I - Dangerous

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Dec 31, 2018 Prescription Drugs View Details →

Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride, QS 10 mL, Injectable Solution, Dwell, 10mL Sterile single use syringe, NDC: 42852-725-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Advanced Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Mar 13, 2019 Compounded Drugs Nationwide View Details →

HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride, QS 5 mL Injectable Solution 1 mg/5 mL (0.2 mg per mL), Sterile single use syringe, NDC: 42852-289-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Advanced Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Mar 13, 2019 Compounded Drugs Nationwide View Details →

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15

AVKARE

Class I - Dangerous

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

Mar 5, 2019 Prescription Drugs Nationwide View Details →

Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc. Made in India, NDC 23155-160-31

Heritage Pharmaceuticals

Class I - Dangerous

Subpotent Drug.

Feb 15, 2019 Prescription Drugs Nationwide View Details →

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100 tablets (10 blister cards of 10 tablets each), Rx only, Manufactured in Israel By: Teva Pharmaceutical Ind. Ltd. Jerusalem, 9777402, Israel, Manufactured for: Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0093-3008-93

Teva Pharmaceuticals USA

Class I - Dangerous

Subpotent Drug.

Mar 11, 2019 Prescription Drugs Nationwide View Details →

Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA. NDC: 51079-788-20

Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Class I - Dangerous

Failed Impurities/Degradation Specifications: Elevated levels of a known impurity detected during 6-month RT stability interval.

Jan 18, 2019 Prescription Drugs Nationwide View Details →

Losartan Potassium Tablets, USP, 50 mg, 30 tablet bottles, Rx Only, Distributed by: Wal-Mart, Bentonville, AR 72716, Manufactured for: Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, Packaged by: Legacy Pharmaceutical Packaging LLC, Earth City, MO 63045. NDC 68645-578-54

Legacy Pharmaceutical Packaging

Class I - Dangerous

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) detected

Mar 1, 2019 Prescription Drugs View Details →

Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 ---- NDC 50268-517-15

AVKARE

Class I - Dangerous

CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified

Mar 5, 2019 Prescription Drugs Nationwide View Details →

Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 --- NDC 52343-123-90

Rising Pharmaceuticals

Class I - Dangerous

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Mar 7, 2019 Prescription Drugs View Details →

Phenylephrine HCl, 1,200 mcg in 0.9% Sodium Chloride, QS 10 mL Injectable Solution 1,200 mcg/10 mL (120 mcg per mL), Sterile single use syringe, NDC: 42852-882-61 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Advanced Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Mar 13, 2019 Compounded Drugs Nationwide View Details →

Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10

Macleods Pharma Usa

Class I - Dangerous

CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.

Feb 21, 2019 Prescription Drugs View Details →

Valsartan Tablets USP 320 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-573-90

Aurobindo Pharma USA

Class I - Dangerous

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Dec 31, 2018 Prescription Drugs View Details →

Neostigmine Methylsulfate Injection Solution 5 mg/5mL (1 mg per mL), 5mL Sterile single use syringe, For IV use only, NDC: 42852-829-67 Avella of Houston 9265 Kirby Dr., Houston, TX 77054 (877) 794-0404

Advanced Pharma

Class I - Dangerous

Lack of Assurance of Sterility

Mar 13, 2019 Prescription Drugs Nationwide View Details →

Valsartan Tablets USP 80 mg, 90 count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ --- NDC 65862-571-90

Aurobindo Pharma USA

Class I - Dangerous

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Dec 31, 2018 Prescription Drugs View Details →