🍔 Food 💊 Drugs 🏥 Medical Devices
Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856179, NDC 43598-561-78 Class II

Reason: FAILED DISSOLUTION SPECIFICATIONS

Dr. Reddy's Laboratories, Inc. 20220713 Terminated
Distributed: Nationwide in the USA
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Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540, Made in India, blister barcode 4359856079, NDC 43598-560-78 Class II

Reason: FAILED DISSOLUTION SPECIFICATIONS

Dr. Reddy's Laboratories, Inc. 20220713 Terminated
Distributed: Nationwide in the USA
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Nifedipine WSP 0.2% Ointment, 60 gram tubes, Rx only, Valor Compounding Pharmacy, 2461 Shattuck Ave., Berkeley, CA 94704 Class I

Reason: Subpotent and Superpotent Drug

Valor Compounding Pharmacy, Inc DBA Valor Compounding Pharmacy 20220627 Terminated
Distributed: CA only
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Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957. Class II

Reason: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864. Class II

Reason: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375. Class II

Reason: Marketed Without An Approved NDA/ANDA: Unapproved Drug based on label claims.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Launch Sequence Aphrodisia Capsules, 4-count tins, ASIN B07QB3S2LV, UPC Code 661020846957. Class I

Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Launch Sequence Euphoria Capsules, 10- count tins, ASIN B08ZJX4V9J, UPC Code 661020846864. Class I

Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Launch Sequence Capsules, Dietary Supplement, 60- count bottles, ASIN B07TLPWXDS, UPC Code 641378938375. Class I

Reason: Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.

Loud Muscle Science 20220627 Terminated
Distributed: The product was distributed nationwide in the USA and Canada.
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Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, Hecho en Mexico por: PLANTAS MEDICINALES DE MEXICO , Melchor Ocampo No. 55 Local D, Delegacion Xochimilco. C.P. 16800, Mexico, D.F., ASIN B084KSV12L, UPC 7 501031 111190 Class I

Reason: Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.

Amazon.com, Inc. 20220526 Terminated
Distributed: Nationwide within the U.S.A.
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