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FDA Recalls
›Drug Recalls

FDA Drug Recalls

Recalls of prescription drugs, over-the-counter medications, and compounded pharmaceuticals.

Classification

All Class I Class II Class III

Status

All Ongoing Completed Terminated

Date

All time Past 30 days Past 12 months

Showing 9161–9180 of 17,793 recalls

Class IIOngoing

Solco Healthcare US Valsartan, USP, 320 MG Tablets, 90-count bottle,Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-370-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan, USP, 80 MG Tablets, 90-count bottle, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-368-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan, USP, 160 MG Tablets, 90-count bottles, Rx Only Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-369-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan, USP, 40 MG Tablets, 30- count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-367-03

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 320 MG/12.5 MG Tablets, 90-count bottle, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-314-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 160 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-312-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IIOngoing

Solco Healthcare US Valsartan and Hydrochlorothiazide, USP, 80 MG/12.5 MG Tablets, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd. Xynqiao, Linhai, Zhejiang 317024, China Distributed by: Solco Healthcare US, LLC Cranbury, NJ 08512 USA NDC 43547-311-09

Prinston Pharmaceutical Inc

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

July 13, 2018 · DrugView details →

Class IITerminated

Testosterone Cypionate Injection, USP, 200 mg/mL, Rx only, 10 mL vials, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries, Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India, NDC 62756-016-40

Sun Pharmaceutical Industries, Inc.

Presence of Particulate Matter: organic and inorganic compounds detected in vials of product.

July 12, 2018 · DrugView details →

Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC a) 36000-002-10 and b) 36000-002-06.

Renaissance Lakewood, LLC

Superpotent Drug: lots out of specification for elevated sodium chloride and fluconazole assay.

July 11, 2018 · DrugView details →

Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 400 mg in 200 mL (2 mg/mL), 200 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India; NDC 36000-003-06.

Renaissance Lakewood, LLC

Superpotent Drug and Failed Stability Specifications: lot out of specification for elevated sodium chloride and elevated water vapor.

July 11, 2018 · DrugView details →

Class IIITerminated

Fluconazole Injection, USP, Iso-Osmotic Sodium Chloride Diluent, 200 mg in 100 mL (2 mg/mL), 100 mL Single Dose Flexible Container bag, Rx only, Manufactured for: Claris Lifesciences Inc., North Brunswick, NJ 08902; By: Claris Injectables Ltd., Gujarat, India, NDC 36000-002-10.

Renaissance Lakewood, LLC

Failed Stability Specifications: lot out of specification for elevated water vapor.

July 11, 2018 · DrugView details →

Class IIITerminated

Diazepam Rectal Gel, 2.5 mg, TWIN PACK that Contains two pre-filled, unit-dose, rectal delivery systems with lubricating jelly and instructions for use per carton, Rx only, Manufactured for: Oceanside Pharmaceuticals, a division of Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807; Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215; NDC 68682-650-20.

Valeant Pharmaceuticals North America LLC

Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.

July 10, 2018 · DrugView details →

Class IIITerminated

Triamterene and Hydrochlorothiazide Tablets, USP 37.5 mg/25 mg, 100-count bottle, Rx only, Mylan Pharmaceuticals, Inc. Morgantown, WV 26505, NDC 0378-1352-01

Mylan Pharmaceuticals Inc.

Subpotent Drug

July 9, 2018 · DrugView details →

Class IITerminated

alba BOTANICA sport mineral sunscreen (titanium dioxide 7.0% and zinc oxide 9.0%), spf 45, 170 g (6 oz) tubes packaged in a) 4 tubes per case; b) 8 pack shipper display; Manufactured By: The Hain Celestial Group, Inc., Lake Success, NY 11042, UPC 7 24742 01102 4.

The Hain Celestial Group, Inc. - Worldwide HQ

Incorrect Product Formulation: wrong sunscreen product in the package.

July 5, 2018 · DrugView details →

Class IIOngoing

Admelog Solostar (insulin lispro injection), 100 units/ mL (U-100) injection, packaged in 3mL prefilled pens, 1 pen per box, Rx only, Physician Sample - Not For Sale, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807, NDC 0024-5925-00

Sanofi-Aventis U.S. LLC

Temperature Abuse: Product samples of Admelog may not have been shipped at proper temperature.

July 5, 2018 · DrugView details →

Class IITerminated

Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.

Teva Pharmaceuticals USA

Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.

July 5, 2018 · DrugView details →

Class IITerminated

Monsel's Solution (Ferric Subsulfate), 20%, packaged as 12 single application vials and 12 applicators, 8 mL per box, Manufactured For: MedGyn Products, Inc., 100 W. Industrial Rd., Addison, IL 60101 USA; Manufactured By: BioDiagnostics Intl, 555 West Lambert Road Unit-C, Brea, CA 92821, NDC 42721-112-08.

Medgyn Products, Inc.

CGMP Deviations: The manufacturer of this product recalled because they were not manufactured under current good manufacturing practices.

July 3, 2018 · DrugView details →

Class IITerminated

Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL (2 mEq/mL), Rx only, Medi-Fare Drug Pharmaceutical Compounding 300 West Pine St., Blacksburg, SC 29702 800-622-0007

Medi-Fare Drug and Home Health Center

CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.

July 3, 2018 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended Release Tablets, USP, 500 mg, packaged in a 500-count bottle, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd. Halol-Baroda Highway, Halol-389 350 Gujarat. India, NDC 62756-142-02

Sun Pharmaceutical Industries, Inc.

Presence of foreign substance: One lot fo Metformin Hydrochloride Extended Release Tablets, USP, 500 mg (500 Count) contains foreign matter identified as a piece of rubber glove detected in one tablet.

July 3, 2018 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection USP 3.375 grams per vial, Single-Dose Vial, Rx Only. Manufactured for: Auromedics Pharma LLC 6 Wheeling Road Dayton NJ 08810, Made in India. NDC 55150-120-30

AuroMedics Pharma LLC

Presence of Particulate Matter: identified as glass and silicone material

July 2, 2018 · DrugView details →

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