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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 12021–12040 of 17,816 recalls

Class IITerminated

Menthocin Patch with Lidocaine-Strong (Menthol 5%, Capsaicin 0.0375%, Methyl Salicylate 20%, Lidocaine 0.5%), packaged in a box 15 patches, RX Only, Manufactured for Bonita Pharmaceuticals LLC 6380 Commerce Drive Westland, MI 48185-9120, USA NDC 53598-0012-15

Bonita Pharmaceuticals, LLC

Marketed without an approved NDA/ANDA

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 10 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-323-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 20 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-324-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Atorvastatin Calcium 80 mg, 10 tablets per blister,100-count package, Rx Only Manufactured by Apotex Inc. Toronto, Ontario, Canada, Packaged by GSMS Inc., Camarillo, CA 93010, NDC # 60429-326-77

Golden State Medical Supply Inc.

Failed Impurities/Degradation Specifications

January 27, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 60 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2997-3; UPC # 360505299737;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Candesartan Cilexetil Tablets, 16 mg, 30 Tablets (5 x 6) blister pack, Rx, Distributed by: American Health Packaging Columbus, Ohio 43217, NDC 68084-877-25(carton), NDC 68084-877-95(individual dose)

Amerisource Health Services

Failed Impurities/Degradation Specifications; 9 month stability (manufacturer)

January 26, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 20 mg, 60-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2995-6; UPC # 360505299560;

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class IIITerminated

Duloxetine Delayed-Release Capsules, USP, 30 mg, 30-count bottles, Rx only, Manufactured by Apotex Inc, Toronto, Ontario M9L 1T9, Manufactured for Apotex Corp. Weston Florida 33326, NDC 60505-2996-3; UPC # 360505299638.

Apotex Scientific, Inc

Failed Dissolution Specification: Out of specification dissolution results when testing product stability.

January 26, 2016 · DrugView details →

Class ITerminated

Metronidazole Injection USP, 500 mg per 100 mL (5 mg/mL), 100mL Sterile Single Dose Container bag, Rx only, Baxter USA, Product Code 2B3421, NDC 0338-1055-48.

Baxter Healthcare Corp.

Presence of Particulate Matter: identified as a cloth fiber.

January 21, 2016 · DrugView details →

Class ITerminated

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Baxter Healthcare Corp.

Presence of Particulate Matter: identified as cardboard.

January 21, 2016 · DrugView details →

Class IITerminated

0.9% Sodium Chloride Injection USP, MINI-BAG Plus Container, 100 mL VIAFLEX Single Dose Container bags, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B0043, NDC 0338-0553-18.

Baxter Healthcare Corp.

Lack of Assurance of Sterility: potential for leaking containers which lacks the assurance of sterility.

January 21, 2016 · DrugView details →

Class ITerminated

CLINIMIX E 5/15 sulfite-free (5% Amino Acid with Electrolytes in 15% Dextrose with Calcium) Injection, 1000 mL Injection Port Chamber 30% Dextrose Injection with Calcium, 1000 mL Outlet Port Chamber 10% Amino Acid Injection with Electrolytes, 2000 mL CLARITY Dual Chamber Container bag, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, Product Code 2B7721, NDC 0338-1123-04.

Baxter Healthcare Corp.

Presence of Particulate Matter: identified as dried skin.

January 21, 2016 · DrugView details →

Class IIITerminated

Cyclopentolate Hydrochloride Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-735-01) and b) 15 mL Bottles (NDC: 24208-735-05), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 0.5%, Packaged in 15 mL Bottles, Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637. NDC: 24208-590-64.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IITerminated

Levofloxacin Tablets USP, 500 mg, packaged in 100-count (10 x 10) blister cards per carton, individual blisters labeled UPC (01) 003 68084 482 11 3, carton labeled NDC 68084-482-01, UPC (01) 0 03 68084 482 01 4; Rx only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217.

Amerisource Health Services

Failed Dissolution Specifications: Unexplained low out of specification results for dissolution.

January 18, 2016 · DrugView details →

Class IITerminated

Nystatin, USP Powder for Rx compounding, 50 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0405-05, UPC 305740404058.

Perrigo Company PLC

Labeling: label error on declared strength.

January 18, 2016 · DrugView details →

Class IIITerminated

Tropicamide Ophthalmic Solution USP, 1%, Packaged in a) 2 mL Bottles (NDC: 24208-585-59) and b) 15 mL Bottles (NDC: 24208-585-64), Rx Only. Bausch and Lomb Incorporated, Tampa, FL, 33637.

Bausch & Lomb, Inc.

Labeling: Incorrect or Missing Package Insert: Package insert is missing updates compared with reference drug insert.

January 18, 2016 · DrugView details →

Class IITerminated

Nystatin, USP Powder for Rx compounding, 150 Million Units, Packaged by Perrigo, Minneapolis MN 55427, NDC 0574-0404-15, UPC 305740404157

Perrigo Company PLC

Labeling: label error on declared strength.

January 18, 2016 · DrugView details →

Class IITerminated

progesterone/testosterone (ss oil) 0.25/20 mg/mL, 10 mL unit size, room temperature, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Abbott's Compounding Pharmacy, Inc.

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

January 15, 2016 · DrugView details →

Class IITerminated

papaverine phentolamine prostaglandin; 25/0.83 mg/10 mcg/mL; 10 mL unit size, refrigerate, This Rx is Compounded, Abbott's Compounding Pharmacy, Berkeley, CA 94705

Abbott's Compounding Pharmacy, Inc.

Lack of Assurance of Sterility: Firm is recalling all unexpired lots of sterile compounded products after FDA inspection found concerns of lack of sterility assurance.

January 15, 2016 · DrugView details →

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