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All recalls8,521 total

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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

A
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.

V
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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NEW YORK WHOLESALE GROUP — Zaarah Herbals brand Vasaka Powder; packaged in 100g clear jars with gold lids; UPC: 6 35028 99967 0

Products contain elevated levels of Lead (Pb): 6.504 ppm

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NEW YORK WHOLESALE GROUP — Zaarah Herbals brand Rasayan Churan; packaged in 100g clear jars with gold lids; UPC:6 35028 99966 3

Products contain elevated levels of Lead (Pb): 88.038 ppm

C
Consumer Product Partners, LLC — [CORRECT FRONT PANEL] Hydrogen Peroxide Topical Solution, USP, 32 FL OZ (1 QT) 946 mL per bottle, NDC 0869-0871-45; [INCORRECT BACK LABEL] Isopropyl alcohol 91%, Dist.

Labeling; Label Mixup; some bottles have an incorrect back label indicating 91% Isopropyl Alcohol

E
Exela Pharma Sciences LLC — 8.4% Sodium Bicarbonate Injection, USP, 50 mEq/50 mL (1 mEq/mL), 25 x 50 mL Single Dose Vials per carton, For Intravenous Use Only, Rx Only, Manufactured by: Exela Pharma S

Lack of Assurance of Sterility

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Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morg

Super-Potent Drug: Out of specification potency results were obtained.

S
Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh,

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

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Slate Run Pharmaceuticals — Cinacalcet Hydrochloride Tablets 30 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh,

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

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Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), Rx Only, 100 Unit Dose Blister Cards of 10 (10 cards of 10 tablets each) per carton, Mylan Pharmaceuticals Inc., Morga

Super-Potent Drug: Out of specification potency results were obtained.

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ASEGUA THERAPEUTICS LLC — Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an affiliate of Gilead Sciences, Inc., F

Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.

D
Direct Rx — Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

D
Direct Rx — Duloxetine D/R, 30 mg, 30 Caps, RX Only, Packaged as a) 30-count bottle NDC 61919-0482-30, b) 60-count bottle, NDC 61919-0482-60, c) 90-count bottle, NDC 61919-0482-90; Packaged & Distri

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

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Great Lakes Coca-Cola Distribution LLC — Coco-Cola Original Taste, 12 Fl Oz. (355mL). Can UPC 0 49000-00634 6. 12-can pack UPC 0 49000-02890 4. Canned Under Authority of the Coca-Cola Company, Atla

Foreign object (plastic)

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QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.125% Bupivacaine HCl 125 mg/100 mL (1.25 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use

Lack of Assurance of Sterility

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QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.1% Bupivacaine HCl 100 mg/100 mL (1 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Co

Lack of Assurance of Sterility

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QuVa Pharma, Inc. — fentaNYL Citrate PF 200 mcg/100 mL (2 mcg/ml) /0.2% ROPivacaine HCl 200 mg/100 mL (2 mg/mL), 100 ml in NS Yellow CADD FSFF, Injection for Epidural Use (Not intended For IV Use), Co

Lack of Assurance of Sterility

B
Blooming Import Inc. — Golden Crop Candy (10 oz. (283g) wrapped candies)

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

B
Blooming Import Inc. — Golden Crop Candy (8 oz. (227g) un-wrapped candies)

Contains undeclared and unallowed colors (Blue 1, Red 40, Acid Red 18)

S
Strides Pharma, Inc. — Testosterone Gel 1%, 5 grams, 30 Unit-dose Packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-152-02

Presence of foreign substance: Presence of Benzene.

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Golden State Medical Supply Inc. — PRASUGREL TABLETS, 5 mg, 30 tablet bottles, Rx only, packaged by GSMS, Incorporated, Camarillo, CA 93012 NDC 51407-444-30

Failed Dissolution Specifications

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Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

S
Strides Pharma, Inc. — Testosterone Gel 1%, 2.5 grams, 30 Unit-dose packets in a carton, Rx only, Distributed by: Strides Pharma Inc., East Brunswick, NJ, NDC 64380-151-02

Presence of foreign substance: Presence of Benzene.

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L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, a) UPC 3606000508804, 20 mL (0.7 fl. oz.) Tube per Carton, b) 88

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

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L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Dermatological Acne System, 3 Step Acne Routine Kit, Medicated Gel Cleanser 3.4 fl. oz. (100 mL) Tube, Clarifying Solution 3.4 fl. oz.

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

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L'Oreal USA — La Roche-Posay Laboratoire Dermatologique Effaclar Duo Dual Action Acne Treatment, 5.5% Benzoyl Peroxide Acne Medication, 40 mL (135 FL. OZ.) Tube per carton, La Roche-Posay LLC, 10 Huds

Chemical Contamination: This recall has been initiated due to detected trace levels of benzene.

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Liaoning Cheng Da (USA) Inc — Wangzhine branded Hot Pot Sauce; Net Weight: 160 Grams, 5.64OZ; 36 units/case; UPC# 6907592001375

(Imported) Hot Pot Sauce contains undeclared allergens (Wheat and Soy)

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