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FDA Recalls

Showing 15,271–15,280 of 18,043 recalls

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🍔 Food 💊 Drugs 🏥 Medical Devices

phosLo (calcium acetate) GelCaps, 667 mg, 200-count bottle, Rx only, Manufactured for Fresenius Medical Care North America, Waltham, MA 02451, NDC 0781-2081-02 Class II

Reason: Cross Contamination with Other Products: Potential for contaminant on the cotton packaging inside the bottle. Chemical analysis of the contaminant found on the cotton was identified as a formulation of 4% Trimipramine methanesulfonate - a tricyclic antidepressant..

Fresenius Medical Care Holdings, Inc. 20140414 Terminated

Distributed: PA

PROMETHAZINE HYDROCHLORIDE Tablets, USP, 25 mg, 100 Tablet Bottles, Rx Only. Manufactured by: Cadila Healthcared Ltd., India. Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534. NDC: 68382-041-01 Class II

Reason: Presence of Foreign Tablets: Presence of atenolol 25 mg tablet mixed into promethazine 25 mg tablet bottles.

Zydus Pharmaceuticals USA Inc 20140508 Terminated

Distributed: Nationwide

QVAR¿ (beclomethasone dipropionate HFA), 80mcg Inhalation Aerosol, 50 metered inhalations/120 metered inhalations, packaged in an aluminum cylinder, Mktd. by: Teva Respiratory, LLC, Horsham, PA, Mfd. by: 3M Drug Delivery Systems, Northridge, CA. Class II

Reason: Defective Delivery System; defective valve

Teva Pharmaceuticals USA 20140423 Terminated

Distributed: Nationwide

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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

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

Schindele Enterprises dba Midwest Wholesale 20140109 Terminated

Distributed: Distributed to PA, IL, TX, IA, GA, CT, FL, CA, LA, NY, MD, NV, and WI

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