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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 12221–12240 of 17,816 recalls

Class IITerminated

Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

November 4, 2015 · DrugView details →

Class IIITerminated

Paricalcitol Capsules, 2 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-664-30

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

November 4, 2015 · DrugView details →

Class IIITerminated

Paricalcitol Capsules, 4 mcg, 30 capsules per bottle, Rx Only, Mfd by: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-665-30

Dr. Reddy's Laboratories, Inc.

Failed Tablet/Capsule Specifications: Product recalled due to reports of breakage and leakage of Paricalcitol capsules.

November 4, 2015 · DrugView details →

Class IITerminated

Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

November 4, 2015 · DrugView details →

Class IITerminated

Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

Pine Pharmaceuticals, LLC

Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.

November 4, 2015 · DrugView details →

Class IIITerminated

Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufactured by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977. Mylan. NDC: 51079-090-20.

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

Failed Impurities/Degradation Specifications: Out of specification for impurities.

November 2, 2015 · DrugView details →

Class IIITerminated

Magnesium Sulfate 7-Hydrate, (For Parenteral Use) USP -GenAR, 100LB, Avantor Performance Materials, Inc., 3472 Corporate Parkway, Suite 200 Center Valley, PA 18034. 610-573-2600.

Avantor Performance Materials Inc

Failed Impurities/Degradation Specifications: Out of specifications results for impurities.

October 30, 2015 · DrugView details →

Class IIITerminated

EPSOM SALT(Magnesium Sulfate Heptahydrate, USP), 50 lb multi-wall bag, Rx only, Manufactured by PQ Corporation, P.O. Box 840, Valley Forge, Pennsylvania USA 19482.

PQ Corporation

Failed Impurities/Degradation Specifications: Level of iron exceeds the limit set by the USP monograph for it (USP limit is NMT 0.5 ug/g (ppm)).

October 29, 2015 · DrugView details →

Class IITerminated

HYDROCHLOROTHIAZIDE CAPSULES, USP, 12.5 mg, 10 cap/blister, 100-count carton, Rx only, Packaged and Distributed by American Health Packaging Columbus, Ohio 43217, NDC 68084-0398-01

Amerisource Health Services

Presence of Particulate Matter

October 29, 2015 · DrugView details →

Class ITerminated

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.3 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0025-5833-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5833-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

Sanofi-Aventis U.S. LLC

Defective Delivery System; potential to have inaccurate dosage delivery

October 28, 2015 · DrugView details →

Class ITerminated

Auvi-Q (epinephrine injection, USP) Auto-Injector, 0.15 mg (a) 2 prefilled auto injectors + 1 trainer (NDC 0024-5831-02) and (b) 1 prefilled auto injector + 1 trainer (NDC 0024-5831-00), Rx Only, Manufactured for Sanofi-Aventis US, LLC Bridgewater, NJ 08807 A Sanofi Company

Sanofi-Aventis U.S. LLC

Defective Delivery System; potential to have inaccurate dosage delivery

October 28, 2015 · DrugView details →

Class IITerminated

GRx HiCort 25 (hydrocortisone acetate 25 mg) Suppositories, 12-count box, Rx only, Distributed by Geritrex Corporation Mount Vernon, NY 10550, NDC 54162-015-12

Geritrex Corp

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

October 27, 2015 · DrugView details →

Class IITerminated

Carbo-O-Philic 40 Cream 40% (Urea) tubes, a) 3 oz (85 g) (NDC 54162-640-03) , b) 7 oz (200 g) (NDC 54162-640-07), Rx Only For topical use only, Distributed by Geritrex Corporation, East Mount Vernon, NY 10550

Geritrex Corp

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

October 27, 2015 · DrugView details →

Class IITerminated

Polyethylene Glycol 3350-GRX Powder 100% jars a) 8.4 oz (250 g) (NDC 54162-335-02), b) Net wt. 16.9 oz (500 g) (NDC 54162-335-05), Distributed by: Geritrex Corporation, Mount Vernon, NY 10550

Geritrex Corp

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

October 27, 2015 · DrugView details →

Class IITerminated

Kindest Kare Antimicrobial Foaming Handwash, Hand Soap, 0.75% Triclosan, 444 ml (15 fl oz) bottles, STERIS Corporation, 7501 Page Avenue, St. Louis, MO 63133, Reorder # 1452-RF, NDC 0519-1452-13, UPC (01)00724995 086251.

Steris Corp

Labeling: Not Elsewhere Classified; Incorrect/Undeclared Excipients: Outdated previous version of label applied to products that incorrectly states one inactive ingredient.

October 27, 2015 · DrugView details →

Class IITerminated

Carbo-O-Philic 40 Gel 40% (Urea) NET WT tube, .5 oz (15 g), Rx Only For topical use only, Distributed byGeritrex Corporation 144, Mount Vernon, NY 10550, NDC 54162-016-15

Geritrex Corp

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

October 27, 2015 · DrugView details →

Class IIITerminated

Meclizine Hydrochloride Tablets USP, 25 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-035-01) and b) 1000 Ct Bottles (NDC: 49884-035-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

Par Pharmaceutical Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

October 26, 2015 · DrugView details →

Class IIITerminated

Meclizine Hydrochloride Tablets, USP, 12.5 mg Tablets, Packaged in a) 100 Ct Bottles (NDC: 49884-034-01) and b) 1000 Ct Bottles (NDC: 49884-034-10), Rx only. Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

Par Pharmaceutical Inc.

Failed Impurities/Degradation Specifications: Out of specification for impurities.

October 26, 2015 · DrugView details →

Class IIITerminated

Duloxetine Delayed-release Capsules, USP, 60 mg, Rx Only, 1000 count bottle, Manufactured by: Laboratorios Dr. Esteve, S.A., Barcelona, Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Boca Raton, FL 33487, NDC: 51991-748-10

Breckenridge Pharmaceutical, Inc

Presence of Foreign Tablets/Capsules: one foreign capsule identified as omeprazole 10 mg was found in the bottle

October 21, 2015 · DrugView details →

Class IIITerminated

RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58.

Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals

Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben.

October 21, 2015 · DrugView details →

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