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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 8521–8540 of 17,773 recalls

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V, Polepally Jadcherla Mahaboob Nagar - 509-301, India. NDC 31722-745-30 UPC 331722745307

Hetero Labs Limited Unit V

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

August 8, 2018 · DrugView details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 160 mg, 90 tablets Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited, Unit V, Pollepally Jadcherla Mahabubnagar - 509-301, India. NDC 31722-747-90 UPC 331722747905

Hetero Labs Limited Unit V

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

August 8, 2018 · Drug

View details →

Class IICompleted

Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 80 mg, 90 count bottles, Rx Only Manufactured for: Camber Pharmaceuticals, Inc. Piscataway NJ 08854 By: Hetero Hetero Labs Limited Unit V. Polepally Jadcherla Mahaboob Nagar - 509-301 India. NDC 31722-746-90 UPC 331722746908

Hetero Labs Limited Unit V

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

August 8, 2018 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg 100-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-01

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

August 7, 2018 · DrugView details →

Class IITerminated

Doxycycline Hyclate USP Tablets, 100 mg packaged in a) 2-count bottles, NDC 55289-866-02; b) 6-count bottles, NDC 55289-866-06; c) 7-count bottles, NDC 55289-866-07; d) 10-count bottles, NDC 55289-866-10; e) 14-count bottles, NDC 55289-866-14; f) 20-count bottles, NDC 55289-866-20; g) 28-count bottles, NDC 55289-866-28; h) 30-count bottles, NDC 55289-866-30; i) 120-count bottles, NDC 55289-866-98; j) 300-count bottles, NDC 55289-866-87; k) 400-count bottles, NDC 55289-866-74; Rx only, Packaged By PD-Rx Pharmaceuticals, Oklahoma City, OK 73127.

PD-Rx Pharmaceuticals, Inc.

Failed Dissolution Specifications: manufacturer West-Ward Pharm Corp. recalled these repackaged lots due to failed dissolution results.

August 7, 2018 · DrugView details →

Class IIITerminated

Diltiazem HCl Extended-Release Capsules, USP 120 mg 500-count bottle, Rx only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505. NDC 0378-5220-05

Mylan Pharmaceuticals Inc.

Failed Impurities/Degradation Specifications: Out of specification test results obtained during routine stability testing for related compound.

August 7, 2018 · DrugView details →

Class IITerminated

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class IITerminated

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19

Teva Pharmaceuticals USA

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

August 6, 2018 · DrugView details →

Class ITerminated

Levothyroxine and Liothyronine (Thyroid Tablets, USP), 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured for: Westminster Pharmaceuticals, LLC, 154 Downing Street, Unit 1 & 2, Olive Branch, MS 38654, NDC 69367-156-04.

Westminster Pharmaceuticals LLC

Failed Content Uniformity Specifications: Product was manufactured using an adulterated active pharmaceutical ingredient; additionally, lack of process controls and good manufacturing practices resulted in finished product failing content uniformity specifications which can result in a product having a strength that is more or less than is labeled.

August 3, 2018 · DrugView details →

Class IITerminated

Thayers Natural Remedies, Saline Nasal Spray, Allergy & Sinus Relief, Slippery Elm, 1.5 FL OZ (44 mL) bottle, Distributed By: Product Quest Manufacturing, LLC, 330 Carswell Ave., Daytona Beach, FL 32117, UPC 7 27510 00660 4.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Premier Value, Saline Nasal Spray, Sodium Chloride 0.65%, packaged as a) 3 FL OZ (88 mL) bottle NDC 68016-388-00 UPC 8 40986 01483 3; b) 1.5 FL OZ (44 mL) bottle NDC 68016-466-00 UPC 8 40986 01482 6, Distributed By Chain Drug Consortium, 3301 NW Boca Raton Blvd, Suite 101, Boca Raton, FL 33431.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

QC Quality Choice, Saline Nasal Gel with Soothing Aloe, 0.5 OZ (14.1 g) tube, Distributed by C.D.M.A., Inc., 43157 W. Nine Mile, Novi, MI 48376-0995, UPC 6 35515 99202 3.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IITerminated

Best Choice, 12 Hour Extra Moisturizing, Nasal Spray (Oxymetazoline Hydrochloride 0.05%), Nasal Decongestant, 1 FL OZ (30 mL) bottle, Proudly Distributed By: Valu Merchandisers, Co., 5000 Kansas Ave., Kansas City, KS 66106, UPC 0 70038 59328 7.

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

Class IIITerminated

Well at Walgreens, Scar Cream with SPF 30, (Avobenzone 3%, Octocrylene 10%, Oxybenzone 6%), 0.7 OZ (19.8 g) tube, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, UPC 3 11917 18281 0.

Product Quest Manufacturing LLC

Subpotent Drug: low out of specification assay results for the octocrylene and avobenzone ingredients.

August 3, 2018 · DrugView details →

Class IITerminated

Rexall, Extra Moisturizing No Drip Nasal Spray (Oxymetazoline Hydrochloride 0.05%) 1 FL OZ (30 mL) bottle, 48 pk. (12687901)

Product Quest Manufacturing LLC

CGMP Deviations: products manufactured under conditions that could impact its product quality.

August 3, 2018 · DrugView details →

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