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All recalls7,877 total

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Glenmark Pharmaceuticals Inc., USA — Prochlorperazine Maleate Tablets, 10mg, 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Saxagliptin Tablets, USP, 2.5mg, a). 30-count bottle (NDC# 68462-726-30), b).90-count bottle(NDC# 68462-726-90), Manufactured by: Glenmark Pharmaceuticals Limited,

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Lacosamide Tablets 150mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: G

CGMP Deviations

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Dr. Reddy's Laboratories, Inc. — Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Dis

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.

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Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules 325mg, 60-count bottle, Rx Only Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 45

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Voriconazole Tablets 50mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Colesvelam Hydrocholoride Tablets 625mg, 180-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Man

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Saxagliptin Tablets 5mg, a). 30-count bottle (NDC# 68462-727-30) b.) 90-count bottle ( 68462-727-90), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, P

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Nitroglycerin Sublingual Tablets 0.4MG 100-count carton, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manu

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Acetaminophen and Ibuprofen (NSAID) Tablets, 250 mg/125 mg a). 144-count packets (NDC# 72657-157-74), b). 216-count packets( 72657-157-76),Distributed by: Glenmark

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Lacosamide Tablets, 100mg , 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Pravastatin Sodium Tablets, USP, 20mg, a).90-count bottle, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceuticals Limited, Pithamp

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Carvedilol Tablets, USP 12.5 mg, 500-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufacture

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules USP, 225mg 60-count bottles, Rx Only, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 45477

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Rufinamide Tablets 200mg, 120-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Pravastatin Sodium Tablets 80mg, 90-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Prad

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Lacosamide Tablets 200mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: G

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Fluphenazine Hydrochloride Tablets, 10mg, 100-Count Bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Ma

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules, USP 325mg,60-count bottles, Rx Only, Mfd for: Northstar Rx LLC, Memphis, TN 38141, Mfd by: Glenmark Pharmaceut

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Rosuvastatin Tablets 40mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Indomethacin Extended-Release Capsules, 75mg, 60-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufac

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Clindamycin Hydrochloride Capsules, USP, 300mg, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manu

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Nitroglycerin Sublingual Tablets 0.3MG, 100-count bottles, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Lacosamide Tablets, 50mg, 60-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for:

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Propafenone Hydrochloride Extended-Release Capsules 225mg, 60-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 4

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Voriconazole Tablets 200 mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Solifenacin Succinate Tablets 10MG, a. 30-count bottle (NDC# 68462-387-30), b. 90-Count Bottle (NDC 68462-387-90),Rx Only, Manufactured by: Glenmark Pharmaceutica

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Teriflunomide Tablets, 14mg, 30-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for

CGMP Deviations

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Glenmark Pharmaceuticals Inc., USA — Fluphenazine Hydrochloride Tablets 2.5mg, 100-count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Ma

CGMP Deviations

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INSTITUT GEORGES LOPEZ — Brand Name: Celsior Cold Storage Solution Product Name: Celsior Cold Storage Solution Model/Catalog Number: 533682 Product Description: In US Celsior is a class II medical

The potential for risk of microbiological contamination of products due to inability to ensure sterility assurance throughout aseptic manufacturing.

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Dairy State Foods Inc — emd Oysterettes (oyster crackers in polypropylene film). 0.75 oz. Packed for and Distributed by emd, Detroit, MI 48212.

Foreign object (metal)

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Julie's Gorditas — Julie's Gorditas De Nata; Ingredients: Flour, Vegetable Oil, Sugar, Baking Soda, Milk, Sour Cream, Butter, Cream Of Milk, Cinnamon, Vanilla; Net Wt. 16.75 OZ UPC# 0 00202 12018 6

undeclared allergen ingredient (wheat) on product label for flour Gorditas.

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FRUSELVA USA — Good & Gather baby Pea, Zucchini, Kale & Thyme Vegetable Puree. Net Wt 4 oz. (113g). 6+ months. UPC 1 91907-99314 1. Distributed by Target Corporation, Minneapolis, MN 55403. Prod

elevated level of lead

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Alchemee, LLC — Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g), UPC 8 42944 10223 1; Distributed by Alchemee,

Chemical contamination: Presence of benzene

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Alchemee, LLC — Proactiv Emergency Blemish Relief (Benzoyl Peroxide 5%), 0.33 oz. (9.45 g), Distributed by Alchemee LLC, Santa Monica, CA 90401, Made in the USA, UPC 7 35786 01921 1, UPC 8 42944 1022

Chemical contamination: Presence of benzene

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KABANA SKIN CARE — GreenScreen, kabana organic skincare, Bread Spectrum UVA & UVB, Zinc Oxide Sunscreen, Organic Ingredients, Fragrance Free, Biodegradable, Chemical Free, Non-Nano, Baby Safe, Origina

cGMP deviations

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KABANA SKIN CARE — Erin's Faces, Mineral SPF 32, UVA/UVB Sunscreen, Broad Spectrum SPF 32, 25% Zinc Oxide, 3 FL OZ/ 85 mL per bottle, Made in USA for Erin's Faces, Millburn, NO 07041. NDC: 73369-140

cGMP deviations

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KABANA SKIN CARE — B Natural Organics, Organic Sunscreen, Broad Spectrum, SPF 30, 25% non-nano Zinc Oxide, a) Nude Tint Mineral Formula for Face and Body, 4 oz. (120 ML) per bottle. NDC: 73369-1002-2;

cGMP deviations

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KABANA SKIN CARE — In Your Face Mineral Tint SPF 31, Zinc Oxide 25%, Tinted Sunscreen Broad Spectrum UVA & UVB chemical free, Organic Ingredients, Biodegradable & Baby Safe, 50 mL - 1.7 fl oz per bott

cGMP deviations

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New Age International, Inc. — Daily Veggies Enoki Mushroom; Product of Korea; Net WT. 200 g (7.05 oz); KEEP REFRIGERATED; Cook through before

Contaminated with Listeria monocytogenes

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C.H. Guenther & Son LLC — 365 Whole Foods Market Small Bites Macaroni & Cheese. Net Wt 8.5 oz (240g) Keep Frozen. UPC 99482499709. Distributed by: Whole Foods Market, Austin, TX

Undeclared allergen (eggs) and pork

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Lins Waha International Corp — Farmer House Preserve Olive Strips

Contains Cyclamates

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Fruit Of The Earth, Inc. — CVS Health Concealing Acne Treatment Cream, CVS, 10% benzoyl peroxide, 1 oz (28 g), Distributed by: CVS Pharmacy, Inc

Chemical contamination: presence of benzene

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FDC Limited — Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India

Defective container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle

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Fruit Of The Earth, Inc. — Walgreens Maximum Strength Tinted Acne Treatment Cream 10% Benzoyl Peroxide/Acne Medication, 0.65 oz (18.4g) tube in a carton; Distributed by: Walgreen CO., 200 Wilmot Rd.,

Chemical contamination: presence of benzene

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Glenmark Pharmaceuticals Inc., USA — chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product

CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.

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Veridance Pharmacal, LLC — Omni-Macs McDonagh Medical Center Dietary Supplement 100 CAPSULES, Suggested Use: 1-3 capsules per day with meals, Distributed by: McDonagh Medical Center Gladstone, MO 6411

Levels of iodine exceeding label claim

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NEW YORK WHOLESALE GROUP — Zaarah Herbals brand Bhringraj Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99973 1

Products contain elevated levels of Lead (Pb): 3.231 ppm and Arsenic (As): 0.958 ppm;

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NEW YORK WHOLESALE GROUP — Zaarah Herbals brand Gurmar Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99969 4

Products contain elevated levels of Lead (Pb): 3.688 ppm

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