🍔 Food 💊 Drugs 🏥 Medical Devices
Captomer [succinic acid (from 100 mg DMSA)] capsules, 65 mg, 45-count bottles, Manufactured By: Thorne Research, Inc., P.O. Box 25, Dover, Idaho 83825, UPC 6 93749 74002 5 Class II

Reason: Marketed Without An Approved NDA/ANDA: Captomer and Captomer-250 are marketed as dietary supplements and labeled to be sourced from Dimercaptosuccinic Acid (DMSA) which is the active ingredient in an FDA approved drug making these products unapproved new drugs.

Thorne Research Inc 20140612 Terminated
Distributed: Nationwide, New Zealand, England, German, Sweden, Ukraine, and Egypt.
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CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufactured for: Cubist Pharmaceuticals, Inc., Lexington, MA 02421, NDC 67919-011-01, UPC 3 67919-011-01 6. Class I

Reason: Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard.

Cubist Pharmaceuticals, Inc. 20140417 Terminated
Distributed: Nationwide and Puerto Rico.
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Dr. Reddy's Metoprolol Succinate Extended Release Tablets, USP 25 mg. 100-count bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories Limited, Batchupally - 500 090 India. NDC55111-466-01 Class II

Reason: Failed Dissolution Specifications: Failure of dissolution test observed at the 18 month time point.

Dr. Reddy's Laboratories, Inc. 20140523 Terminated
Distributed: Nationwide
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Meizitang Strong Version Botanical Slimming, Soft Gel Capsules, 650 mg, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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Magic Slim capsules, supplied in 60 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: N-desmethylsibutramine, benzylsibutramine, and sibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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Slim Xtreme Weight loss capsules, 500 mg, supplied in 30 count bottles, Another product from Globe All Wellness, LLC Hollywood, FL 33020, distributed by MyNicKnaxs, LLC Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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Meizi Evolution Soft Gel Capsules, supplied in 30 count bottles, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: N-desmethylsibutramine, benzylsibutramine, and sibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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SlimEasy Herbs Capsule, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: sibutramine and N-desmethylsibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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Pill for weight reduction, (Japanese Chinese Formula from Japan Hokkaido Cangye Pharmacy Co, Ltd) 400 mg, supplied in 40 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredient: Phenolphthalein

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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Super Fat Burning Bomb Capsules, 400 mg, supplied in 30 count boxes, distributed by MyNicKnaxs, LLC, Deltona, FL Class I

Reason: Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared active pharmaceutical ingredients: Phenolphthalein and N-desmethylsibutramine

MyNicNaxs, Inc. 20140124 Terminated
Distributed: Nationwide
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