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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 15161–15180 of 17,832 recalls

Class IITerminated

Dermamedics Calm and Correct Serum, 2 oz. containers with a SKU number of BB10062 and 4 oz. containers with a SKU number of BB10068.

Dermamedics, L.L.C.

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

January 10, 2014 · DrugView details →

Class ITerminated

SEXY MONKEY, 2000 mg, 1 count blister, Distributed by A Herbal Bio, Inc., Bayside, NY.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class ITerminated

XZONE GOLD, 1 capsule blister 750 mg, Distributed by: XZONE, Orlando, FL.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class ITerminated

ExtenZe 600 mg, 30 tablet box, Manufactured for: Biotab Nutraceuticals, Inc., Pasadena, CA.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class ITerminated

BOOST ULTRA, sexual enhancement dietary supplement, 12-capsule/bottle. Also packaged in 3 pill bottles and 1 pill packs. BoostUtra.com, Springfield, MO.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class ITerminated

XZEN PLATINUM, 750 mg, Distributed by: XZEN, Los Angeles, CA.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class ITerminated

Magic For Men, packaged in 1ct blister pack and 12-pill/bottle, 390 mg Manufactured For: BTQ Ski, Inc., Chicago, IL 60638

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class IITerminated

Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Maintenance Electrolytes with Phosphorus, 1000 mL bag, Rx only. Hospira Inc, Lake Forest, IL, 60045. NDC: 0409-4196-05

Hospira Inc.

Lack of Assurance of Sterility; potential leakage from administrative port.

January 9, 2014 · DrugView details →

Class ITerminated

MiracleZEN Platinum, 1 pill blister pack, 2000 mg capsule, Distributed by: Power Life Distributors, COK Inc., Los Angeles, CA.

Schindele Enterprises dba Midwest Wholesale

Marketed Without an Approved NDA/ANDA: These dietary supplements contain undeclared sildenafil, an analogue of sildenafil, and/or tadalafil.

January 9, 2014 · DrugView details →

Class IITerminated

Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in 0.9% Sodium Chloride Injection, Rx only. Hospira, Lake Forest, IL 60045. NDC 0409-7620-59.

Hospira Inc.

Lack of Assurance of Sterility; potential leakage from administrative port.

January 9, 2014 · DrugView details →

Class IITerminated

a) Walgreens Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Dist by Walgreen Company, 200 Wilmot RD Deerfield IL 60015 b) Family Wellness Lansoprazole Delayed Release Capsules, USP 15 mg/Acid Reducer, 14 capsules per Bottle, Distributed by Family Services Inc .10401 Monroe Road, Matthews, NC 28105 USA c) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 14 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 d) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 28 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895 e) Equate Lansoprazole Delayed-Release Capsules USP, 15 mg Acid Reducer, 14 capsules per Bottle, and 28 capsules per bottle (Twin Pack)Distributed by Wal-mart Stores Inc. Bentonville, AR 72716 f) CVS Pharmacy Lansoprazole Delayed Release Capsules, 15 mg, Acid Reducer, 42 safety sealed capsules per Bottle, Distributed by CVS/pharmacy Inc, One CVS Drive, Woonsocket, 02895

Dr. Reddy's Laboratories, Inc.

Microbial Contamination of Non-Sterile Products: Out-of-specification results for microbial count were observed at the initial stability interval for Lansoprazole Delayed Release Capsules.

January 3, 2014 · DrugView details →

Class IIITerminated

Zithromax (azithromycin for injection), 500 mg/vial, Sterile, Rx Only, For I.V. infusion only, No latex, No preservative, Made in Ireland, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-3150-84

Pfizer Inc.

Failed Impurities/Degradation Specifications: Pfizer is recalling certain lots due to out of specification results for azithromycin N-oxide degradant.

January 2, 2014 · DrugView details →

Class IITerminated

Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .

Mangiacotti

Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.

December 27, 2013 · DrugView details →

Class IITerminated

Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Salcette, Goa, 403 722 INDIA. Distributed by: Watson Pharma Ltd, Parsippany, NJ 07054. NDC 0591-5513-05.

Watson Laboratories Inc

Presence of Foreign Substance; metal particulates were visually observed in the tablets.

December 23, 2013 · DrugView details →

Class ITerminated

Lidocaine HCl Injection, USP, 2%, 20 mg per mL, packaged in 5-mL single-dose vials, 10 vials per box, Rx Only, Hospira, Inc., Lake Forest, IL. 60045, NDC 0409-2066-05.

Hospira Inc.

Presence of Particulate Matter- Confimed customer complaint of particulates embedded in glass container and in contact with product solution.

December 23, 2013 · DrugView details →

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