FDA Drug Recalls

Natrum Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64191 0.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

R2103, Active Ingredients: Berberis Aquifolium 3x; Borax 3; , Kreosotum 10X; Sepia 3x. Inactive ingredient: 28% dilution alcohol, packaged in a) 470 mL bottle and b) 1000 mL bottle; Manufactured for Wisconsin Pharmacal Company, By: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

November 8, 2019 · Drug

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Magnesia Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64197 2.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Kali Muriaticum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64194 1.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Calcarea Fluorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64188 0.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Ferrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64198 9.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Kali Sulphuricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64196 5.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Cell Salts Combination 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64200 9.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Calcarea Phosphorica 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64189 7.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Class ITerminated

UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) four pack, c) ten pack capsules per carton, Exclusively Manufactured and Formulated by: Buy Wise Marketing, 4234 I-75 Business Spur, Sault Ste Marie, MI 49783, Ultimatepleasure2.com.

Med Man Distribution, Inc.

Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovered through FDA analysis.

StellaLife VEGA Oral Gel Rinse (In equal parts of: Azadirachta Indica 1x, Calendula Officinalis 1x, Echinacea Purpurea 1x, Plantago Major 1x), packaged in 1000 mL white plastic bottle.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Natrum Phosphoricum 6X Tablets, 300-count bottle, 30g, Manufactured in India exclusively for: Washington Homeopathic Products, Inc., 260 JR Hawvermale Way, Berkeley Springs, WV 25411, barcode 7 40640 64192 7.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Pareira (Brava) 1X Tincture, 50 mL bottle, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.

Washington Homeopathic Products, Inc.

CGMP Deviations: products were not manufactured under current good manufacturing practices.

Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5mL) 474 mL bottle, Rx only Distributed by: Aurobindo Pharma USA Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 Made in India NDC 65862-431-74

AuroMedics Pharma LLC

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Aurobindo Ranitidine Capsules 300 mg, 30-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-145-30

AuroMedics Pharma LLC

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Aurobindo Ranitidine Caspules 150 mg, 60-count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-60

AuroMedics Pharma LLC

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

Aurobindo Ranitidine Capsules 150 mg, 500 count bottle, Rx Only Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520 NDC 59651-144-05

AuroMedics Pharma LLC

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.

Golden State Medical Supply Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.

DG Health Acid Reducer Ranitidine Tablets 150 mg, 8-count carton, Distributed by: Dolgencorp LLC 100 Mission Ridge Goodletville TN 37072 NDC 55910-092-79

AuroMedics Pharma LLC

CGMP Deviations: N-nitrosodimethylamine (NDMA) has been detected in Ranitidine tablets, capsules and syrups.

GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.

Golden State Medical Supply Inc.

CGMP Deviations: Presence of NDMA impurity detected in product.