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Drugs Recalls

Prescription and over-the-counter medications

17,685 Total Recalls

Losartan potassium tablets USP, 25 mg, 90- count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3160-9

Apotex

Class I - Dangerous

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

May 29, 2015 Prescription Drugs Nationwide View Details →

Azithromycin tablets, USP 500mg, packaged in 10-count blisters (NDC 68084-279-11); 3 blister packs per carton (NDC 68084-279-21); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Lisinopril tablets, USP 5mg packaged in 10-count blisters (NDC 68084-060-11); 10 blister packs per carton (NDC 68084-060-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

SLIM-K, 30 Capsules, barcode 160126417509, Distributed by: Bethel Inc.

Bethel Nutritional Consulting

Class I - Dangerous

Marketed Without An Approved NDA/ANDA: Product was found to contain sibutramine, desmethylsibutramine and phenolphthalein based on FDA sampling and analysis.

Dec 19, 2014 Prescription Drugs Nationwide View Details →

Magnesium Sulfate Injection, USP, 50%, 20mL, Single dose Fliptop Vial, For IV or IM use, Rx only, Manufactured by Hospira, Inc. 4285 Wesleyan Blvd Rocky Mount, NC 27804 for Hospira, Inc. 275 N Field Drive, Lake Forest, IL 60045. NDC 0409-2168-02

Hospira

Class I - Dangerous

Failed pH Specifications: 12 month stability testing

May 19, 2015 Prescription Drugs Nationwide View Details →

Lisinopril tablets, USP 40mg packaged in 10-count blisters (NDC 68084-064-11); 10 blister packs per carton (NDC 68084-064-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Azithromycin tablets, USP 250mg, packaged in 10-count blisters (NDC 68084-278-11); 10 blister packs per carton (NDC 68084-278-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

0.9% Sodium Chloride Injection, USP, in 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0049-02

Baxter Healthcare

Class I - Dangerous

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Mar 24, 2015 Prescription Drugs View Details →

Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.

Mylan Pharmaceuticals

Class I - Dangerous

Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.

Jun 30, 2015 Prescription Drugs Nationwide View Details →

Amlodipine besylate tablets, USP 10 mg, packaged in 10-count blisters (NDC 68084-506-11); 10 blister packs per carton (NDC 68084-506-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Famotidine tablets, USP 20mg, packaged in 10-count blisters (NDC 68084-172-11); 10 blister packs per carton (NDC 68084-172-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Lisinopril tablets, USP 20mg packaged in 10-count blisters (NDC 68084-062-11); 10 blister packs per carton (NDC 68084-062-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Amlodipine besylate tablets, USP 5mg, packaged in 10-count blisters (NDC 68084-505-11); 10 blister packs per carton (NDC 68084-505-01); Rx only, Manufactured by: Wockhardt Limited, Mumbai, India, Distributed by: Wockhardt, USA, LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA for American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217.

American Health Packaging

Class I - Dangerous

CGMP Deviations: Firm did not adequately investigate customer complaints.

Jun 1, 2015 Prescription Drugs Nationwide View Details →

Bupivacaine Hydrochloride Inj., USP, 0.5% (5 mg/mL), Preservative-Free, 30 mL Single Use Vials, Rx only. HOSPIRA, INC., LAKE FOREST, IL 60045 USA. NDC: 0409-1162-02.

Hospira

Class I - Dangerous

Presence of Particulate Matter: Presence of free-floating and embedded iron oxide particles.

Apr 23, 2015 Prescription Drugs Nationwide View Details →

5% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0017-02

Baxter Healthcare

Class I - Dangerous

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Mar 24, 2015 Prescription Drugs View Details →

Lactated Ringers Injection, USP, 250mL VIAFELX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0117-02

Baxter Healthcare

Class I - Dangerous

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Mar 24, 2015 Prescription Drugs View Details →

Adrucil (fluorouracil injection, USP) Pharmacy Bulk Package Not for Direct Infusion, 5 g/100 mL (50 mg/mL), For Intravenous Use Only, Rx Only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-3019-11

Teva Pharmaceuticals USA

Class I - Dangerous

Presence of Particulate Matter: Black particulate matter was identified as aggregate of silicone rubber pieces from a filler diaphragm and fluorouracil crystals.

Apr 28, 2015 Prescription Drugs Nationwide View Details →

Losartan potassium tablets USP, 100 mg, 90-count bottle, Rx only, Manufactured for Apotex Inc 150 Signet Drive, ON M9L1T9 by Apotex Research Private Limited, Plot 1 & 2, Bommasandra Industrial Area, 4th Phase Jigani Link Road, Bangalore, Karnataka, 560099, India NDC 60505-3162-9

Apotex

Class I - Dangerous

Failed Content Uniformity Specifications: The product may not meet the limit for blend uniformity specification.

May 29, 2015 Prescription Drugs Nationwide View Details →

10% Dextrose Injection, USP, 250mL VIAFLEX Plastic bags, Manufactured by Baxter Healthcare Corporation 65 Pitts Station Road Marion, North Carolina 28752-7925 for Baxter Healthcare Corporation 1 Baxter Pkwy Deerfield, IL 60015-4625. NDC 0338-0023-02

Baxter Healthcare

Class I - Dangerous

Presence of Particulate Matter: Products recalled due to presence of particulate matter (metal)

Mar 24, 2015 Prescription Drugs View Details →

Maximum Strength Analgesic Thera-Gesic Pain Relieving Creme Relief from: Joint and Muscle Soreness, Arthritis, Back Aches; 1/8 Oz Sachet, OTC, Manufactured for Mission Pharmacal Company 10999 IH 10 West, Suite 1000 San Antonio, TX 78230 by Mission Pharmacal Company 38505 IH 10 West Boerne, TX 78006. NDC 0178-0320-12

BioComp Pharma

Class I - Dangerous

Subpotent Drug: menthol and methyl salicylate below specification

Jul 6, 2015 Over-the-Counter Nationwide View Details →