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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 17121–17140 of 17,860 recalls

Class IITerminated

Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IITerminated

Test Cyp 250 mg-lidocaine 5 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IITerminated

Itraconazole 1% eye ointment, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IITerminated

HCG 2000 units/ml, 30 mL syringe, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IITerminated

Test Cyp 50 mg-estradiol cyp 2 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IITerminated

Test cyp 35 mg/ml, Clinical Specialties Compounding Pharmacy, 318 Baston Road, Augusta, GA 30907

Clinical Specialties Compounding Pharmacy

Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes

March 20, 2013 · DrugView details →

Class IIITerminated

Disulfiram Tablets USP 250 mg, 100 tablet bottle, Rx only, Manufactured for TEVA Pharmaceuticals, USA, Sellersville, PA --- NDC 0093-5035-01

Teva Pharmaceuticals USA, Inc.

CGMP Deviation; cotton coil is missing in some packaged bottles

March 19, 2013 · DrugView details →

Class IIITerminated

Tizanidine Tablets USP, 4 mg, 150-count tablets per bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachepally - 500 090 India; NDC 55111-180-15.

Dr. Reddy'S Laboratories

Labeling Illegible: There is a possibility that the bottle labels do not contain the strength of the product as well as other printing details.

March 19, 2013 · DrugView details →

Class IITerminated

Ethambutol Hydrochloride Tablets, USP, 100 mg, 100-count tablets per bottle, Rx only, Mfd. for: Versapharm Incorporated, Marietta, GA; Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; NDC 61748-011-01.

West-ward Pharmaceutical Corp.

Subpotent Drug: Out Of Specification results for assay at the stability time-point of 24 months.

March 18, 2013 · DrugView details →

Class IITerminated

Donnatal Extentabs, 0.3888mg/46.8mg, 100-count bottle (NDC # 66213-421-10), Rx only Manufactured By: West-ward Pharmaceutical, 435 Industrial Way West, Eatontown, NJ 07724 Manufactured For: PBM Pharmaceuticals, Inc. Gordonsville, VA 22942.

West-ward Pharmaceutical Corp.

Labeling: Incorrect or Missing Lot and/or Exp Date: Bottled product is labeled with an expiration date of Apr 2015. The correct expiration is Apr 2013.

March 18, 2013 · DrugView details →

Class IIITerminated

Camila 0.35 mg Tablets, 6 cards of 28 pills, Dist. By: Physicians Total Care, Tulsa, OK --- NDC 54868-4814-0, MFG By TEVA Pharmaceuticals USA, Sellersville, PA

Physicians Total Care, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 18, 2013 · DrugView details →

Class IIITerminated

Oxcarbazepine Tablets, 150 mg, packaged in a) 10 x 10 count Unit-Dose Tablets in blisters packaged in a carton (NDC 0054-0097-20) and b) 100-count bottle (NDC 0054-0097-25), Rx only, Roxane Laboratories, Inc., Columbus, Ohio 43216

Boehringer Ingelheim Roxane Inc

SubPotent Drug: The firm discovered out of specification results for assay and the extended investigation revealed the potential for lower weight tablets.

March 18, 2013 · DrugView details →

Class ITerminated

Piperacillin and Tazobactam for Injection, USP, 40.5 grams per Pharmacy Bulk Package vial, Rx only, Mfg. by: Hospira Healthcare India Pvt. Ltd., Irungattukottai - 602 105, India; Mfg. for: Apotex Corp., Weston, FL 33326, NDC 60505-0773-0.

Apotex Corp.

Crystallization: Potential to exhibit precipitation/crystallization in IV bag or IV line upon reconstitution.

March 18, 2013 · DrugView details →

Class IIITerminated

Cherry Cepacol Sore Throat Lozenges, Benzocaine 15 mg | Menthol 3.6 mg, a)16-count, NDC 63824-711-16 b) Institutional Size, 576-count, NDC 63824-711-98, OTC, Dist. by: Reckitt Benckiser, Parsippany, NJ 07054

Reckitt Benckiser Inc

Subpotent Drug: Product did not conform to the 18-month stability test specification for active Free Benzocaine.

March 18, 2013 · DrugView details →

Class IITerminated

"Well at Wallgreens" Regular Strength Antacid Liquid (Alumina/Magnesia/Simethicone/Antacid & Anti Gas); Mint, a)12 oz bottle (NDC 0363-0073-02), b) 26 oz. bottle (NDC 0363-0073-26), Distributed by Walgreens CO., 200 Wilmot Rd, Deerfield, IL 60015.

Tarmac Products, Inc. d.b.a. Axara Pharmaceuticals

Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.

March 16, 2013 · DrugView details →

Class IIITerminated

Errin (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0344-58

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

Class IIITerminated

Junel(TM) Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets, USP and ferrous fumarate tablets), 28 day regimen, Rx only, Barr laboratories, Pomona, NY --- NDC 0555-9028-58

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

Class IIITerminated

Lessina(R) (Levonorgestrel and ethinyl estradiol tablets, USP) 0.1 mg/0.02 mg, 28 day regimen, Rx only, Barr Laboratories Inc., Pomona, NY --- NDC 0555-9014-67

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

Class IIITerminated

Camila (norethindrone tablets, USP), 0.35 mg, 6 blister cards per carton, 28 tablets each, 28 day regimen, Rx Only, Teva Pharmaceuticals USA, Sellersville, PA 18960, NDC 0555-0715-58

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

Class IIITerminated

Jolessa(R) (levonorgestrel/ethinyl estradiol tablets, USP) 0.15 mg/0.03 mg, 91 day regimen, Rx only, Manufactured by Barr Laboratories, Inc., Pomona, NY, manufactured for TEVA Pharmaceuticals USA, Sellersville, PA ---NDC 0555-9123-66

Teva Pharmaceuticals USA, Inc.

Failed Impurity/Degradation Specification; an impurity identified as N-Butyl-Benzene Sulfonamide (NBBS) was detected during impurity testing

March 15, 2013 · DrugView details →

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