🍔 Food 💊 Drugs 🏥 Medical Devices
VoLumen Barium Sulfate Suspension (0.1 % w/v, 0.1 ww/w), 450 mL bottle, Rx Only. Manufactured by E-Z-EM Canada Inc. a subsidiary or E-Z-EM, Inc. Lake Success, NY 11042. NDC 32909-945-03. Class III

Reason: Failed Stability Testing: This product is below specification for preservative content.

Bracco Diagnostics Inc 20131216 Terminated
Distributed: Nationwide including Puerto Rico
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Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. Class II

Reason: Failed Tablet/Capsule Specifications: Split tablets were found in the 12-month stability samples.

Watson Laboratories, Inc.-(Actavis) - Florida 20131220 Terminated
Distributed: Nationwide
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Oxcarbazepine Tablets, 300 mg, 100 tablet bottles, Rx Only. Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijiah McCoy Drive, Detroit, MI, 48202. Manufactured by: Sun Pharmaceutical Ind. Ltd., Acme Plaza, Andheri-Kurla Road, Andheri (East), Mumbai-400 059, India. NDC 62756-184-88, Rx only, 100 Tablets; Pharmacist: Dispense the Medication Guide provided separately to each patient. Each film-coated tablet contains 300 mg oxcarbazepine, USP, Usual Dosage: See package insert, Dispense in tight container (USP) tore at 25 C (77 F) excursions permitted.... Distributed by Caraco Pharmaceuticals Detroit, MI.... Class II

Reason: Failed Tablet Specifications: Broken Tablets Present.

Caraco Pharmaceutical Laboratories Ltd. 20140129 Terminated
Distributed: Nationwide
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Dr. Reddy's Metoprolol Succinate Extended-Release Tablets USP, 50 mg 100 tablets Rx Only Mfd. By: Dr. Reddy's Laboratories Limited Bachepalli -500 090 INDIA NDC 55111-467-01 Class II

Reason: Failed Dissolution Specification; 12-Month stability interval.

Dr. Reddy's Laboratories, Inc. 20131213 Terminated
Distributed: LA, MI, MO, MS & OH
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Pyridostigmine Bromide Tablets USP, 60 mg, 100 count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC Middlesex, NJ 08846, NDC 64720-128-10 Class II

Reason: Failed Dissolution Specification: Corepharma Inc. is recalling Pyridostigmine Bromide Tablets USP 60 mg due to an out of specification dissolution test generated at the 30 month stability time point.

Corepharma LLC 20131213 Terminated
Distributed: Nationwide and Puerto Rico
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Dollar General Triple Antibiotic Ointment; NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY DOLGENCORP LLC, GOODLETTSVILLE, TN 37072 Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Faria Limited LLC dba Sheffield Pharmaceuticals 20131122 Terminated
Distributed: Nationwide
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FAMILY wellness Triple Antibiotic Ointment. NET WT 1 OZ (28 g), OTC, DISTRIBUTED BY: FAMILY DOLLAR SERVICES, INC., MATTHEWS,NC 28105 Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Faria Limited LLC dba Sheffield Pharmaceuticals 20131122 Terminated
Distributed: Nationwide
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Dr. Sheffield Triple Antibiotic Ointment, OTC a) 0.33 oz (9g) (NDC 11527-162-47); b) 1 oz (22g) (NDC 11527-163-55) SHEFFIELD PHARMACEUTICALS, New London, CT 06320 Class II

Reason: Microbial Contamination of Non-Sterile Products: Elevated counts of gram positive rods were found during environmental testing

Faria Limited LLC dba Sheffield Pharmaceuticals 20131122 Terminated
Distributed: Nationwide
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Hydralazine HCL Tablets, USP, 50 mg in a single blister package, Rx only, Manufactured in Czech Republic by: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0555-89 (carton) and 00182-0555-00 (single blister). Class II

Reason: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

Teva Pharmaceuticals USA 20131218 Terminated
Distributed: Nationwide
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Hydralazine HCL Tablets, USP, 25 mg in a single blister package, Manufactured in Czech Republic By: Teva Czech Industries s.r.o. Opava-Komarov, Czech Republic, Distributed by Goldline Laboratories, Sellersville, PA, NDC 00182-0554-89 (carton) and 00182-0554-00 (single blister). Class II

Reason: Failed Impurities/Degradation Specifications:There is a potential for the tablets to be out of specification for impurities throughout shelf life.

Teva Pharmaceuticals USA 20131218 Terminated
Distributed: Nationwide
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