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All recalls7,877 total

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by:

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Produ

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by:

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc.

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by:

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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Glenmark Pharmaceuticals Inc., USA — Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Produc

cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.

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JR Watkins — Cooling Menthol Extra Strength Pain Relief Patch, Menthol 7.5%, packaged in box of 5, Distributed by J.R. Watkins LLC, Oakland CA 94612 UPC 8 56294 00878 5, NDC 72342-100-05

cGMP Deviations

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Curio Spice Co. — Curio Spice Co. brand Grains of Paradise (Korerima) - Jar 1.25 oz net wt. UPC: 672975171032

Product may be contaminated with mold.

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Legally Addictive Foods — LEGALLY ADDICTIVE THE O.G. COOKIES MADE FROM CRACKERS+TOFFEE+CHOCOLATE+SEA SALT NET WT. 4.7OZ (133G) UPC 8 54766 00802 8 & 1.34OZ (38G) UPC 8 54766 02800 4

The firm received complaints of a "rancid taste" from consumers.

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Noven Pharmaceuticals Inc — Xelstrym (dextroamphetamine) transdermal system, 13.5 mg dextroamphetamine/9 hours, 30 individually sealed transdermal patches, inside a foil-sealed polypropylene tray, pac

Defective Delivery System: The product does not meet predetermined specifications for Coldflow (adhesive).

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Deseret Biologicals Inc — DesBio lunaSOMM Natural Sleep Support Dietary Supplement capsules, 30 count in a Blue PET bottle with a White cap. Supplement facts declare Phosphatidylserine (from non-GMO

Product contains undeclared soy lecithin.

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Baxter Healthcare Corporation — Regadenoson Injection, 0.4 mg/5 mL (0.08 mg/mL), 5mL Single-Dose Pre-filled Syringe, Rx only, Manufactured by: Baxter Pharmaceutical Solutions, LLC, Bloomington, IN 474

Labeling: Missing Label

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SAVENCIA CHEESE USA — Aldi Emporium Selection Brie 8oz UPC 4099100084016; 12 retail units per case La Bonne Vie Brie 8oz UPC 820581678531; 6 retail units per case (No Brand) Industrial Brie 8oz UPC 0

potential to be contaminated with Listeria monocytogenes

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SAVENCIA CHEESE USA — Glenview Farms Spreadable Brie 2, 3lb tubs per case

potential to be contaminated with Listeria monocytogenes

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R. Walters Foods, Limited Liability Corporation — Hannaford brand seafood salad; Net Wt. 12 oz. (340g); INGREDIENTS: SEAFOOD BLEND (FISH PROTEIN [ALASKA POLLOCK AND/OR PACIFIC WHITING], WATER, WHEAT S

Product contains undeclared hydrolyzed soy protein.

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Englewood Cannery — Traditional Country Canning Spaghetti Sauce, Net Wt. 16 oz. (453g), packaged in glass jars with metal lids, 12 jars per case

Undeclared allergen - egg

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SAVENCIA CHEESE USA — La Bonne Vie Camembert 8oz UPC 820581678616; 6 retail units per case

potential to be contaminated with Listeria monocytogenes

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VIONA PHARMACEUTICALS INC — Dapsone Gel 7.5%, 60 gram pump, Rx Only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed by: Viona Pharmaceuticals Inc., Cranford, NJ 07016, NDC 725

Crystallization

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Dr. Reddy's Laboratories, Inc. — IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

Failed Tablet/Capsule Specifications

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FDC Limited — Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals

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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Grand Central Bakery FRE Co Inc — U-BAKE Chicken Pot Pie, frozen product and packaged in heat-sealable polypropylene film. Net wt. 11.5oz. Made by Grand Central Baking Company. Label declares Wheat

Undeclared egg

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Grand Central Bakery FRE Co Inc — U-BAKE Marionberry Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 4oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.

Undeclared egg

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Grand Central Bakery FRE Co Inc — U-BAKE Apple Pie, frozen product and packaged in LDPE bag, net wt. 2lbs. 9oz. Made by Grand Central Baking Company. Label declares Wheat and Milk.

Undeclared egg

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MAMTAKIM, Inc. — BELEVINI, DRIED FRUIT MIX (Apples, Pears & Plums w/pit), 500g, PLASTIC SOFT PACK, 6 PACKAGES PER CASE

Product contains undeclared sulfites. The product was sampled by the NYSAGM s Food Safety Division and tested positive at 120.7 PPM Sulfites.

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Grand Central Bakery FRE Co Inc — U-BAKE Pie Crust (Pastry Round), frozen product and packaged in LDPE bag, 2-10.5 inch pie crust per package, net wt. 20oz. Made by Grand Central Baking Company. Label

Undeclared egg

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Lannett Company Inc. — Lisdexamfetamine Dimesylate Capsules, 10 mg, 100 Capsules per bottle, Rx only, Distributed by: Lannet Company, Philadelphia, PA 19136, NDC: 0527-4661-37

Failed Content Uniformity Specifications: Product failed to meet the action limits for stratified content uniformity.

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Unexo Life Sciences Private Limited — THERACARE Cold Hot Medicated Patch, Menthol 5%, 5 patches per box, Manufactured for: Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-954-05, UPC 8 45717 008

cGMP Deviations

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Unexo Life Sciences Private Limited — ABSORBINE jr. Extra Large BACK PATCH, Menthol 5%, 1 extra large patch per box, Distributed By: Absorbine Jr., LLC, Chattanooga, TN 37402 UPC 8 89476 41218 6, UPC

cGMP Deviations

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Unexo Life Sciences Private Limited — PARCHE LEON PAIN RELIEVING HOT PATCH, Camphor 3%, Menthol 1.25%, Capsaicin 0.025%, 6 patches per box, Distributed by: Pharmadel LLC, Georgetown, DE 19947 NDC 5575

cGMP Deviations

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Unexo Life Sciences Private Limited — THERACARE MAXIMUM STRENGTH PAIN RELIEF 4% LIDOCAINE PATCH, a) 1 patch (NDC 71101-001-24, UPC 8 45717 00878 5) and b) 6 patches (NDC 71101-001-06, UPC 8 45717 0105

cGMP Deviations

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Unexo Life Sciences Private Limited — LILAS Feminine Pain Relief Patch, Menthol 10%, a) 5 patches per box (UPC 7 87099 48212 1) and 10 patches per box (UPC 7 87099 48211 4), Distributed by: Lilas Well

cGMP Deviations

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Unexo Life Sciences Private Limited — EQUATE MAXIMUM STRENGTH LIDOCAINE PAIN RELIEVING PATCH Lidocaine 4% Topical Anesthetic, 6 patches per box PATCHES, LIDOCAINE 4%, Distributed by: Walmart Inc., Ben

cGMP Deviations

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Unexo Life Sciences Private Limited — JR WATKINS COOLING PAIN RELIEF PATCHES, Menthol 7.5%, 5 patches per box, Distributed By: J.R. Watkins, LLC, Oakland, CA 94612 UPC 8 56294 00878 5

cGMP Deviations

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Unexo Life Sciences Private Limited — ABSORBINE jr ULTRA STRENGTH PAIN PATCH, Menthol 6.5%, 1 patch per box, Distributed By: Absorbine Jr. LLC, Chattanooga, TN 37402 UPC 8 89476 41318 3, UPC 8 89476 4

cGMP Deviations

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Unexo Life Sciences Private Limited — CHEEKY BONSAI PAIN RELIEF PATCHES, Menthol 10%, 4 patches per box, Distributed by Cheeky Bonsai, San Francisco, CA UPC 8 60006 57564 9

cGMP Deviations

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Unexo Life Sciences Private Limited — ABSORBINE JR PAIN RELIEVING KNEE PATCH, Camphor 7%, Menthol 7%, packaged in a) 1 patch (UPC 8 89476 41251 3) and b) 6 patches (UPC 8 89476 41306 0), Distributed B

cGMP Deviations

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Unexo Life Sciences Private Limited — HealthWise PERIOD PATCH Menstrual Pain Relief, Menthol 10%, 10 patches per box, Manufactured for Veridian Healthcare, LLC, Gurnee, IL 60031 NDC 71101-947-10, UPC

cGMP Deviations

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JR Simplot Company — Item #473015 Simplot seasoned CRISP Delivery+ Savory 6 Cut Crinkle Cut Wedge, Frozen Potatoes, 5lb. bag without any labeling, 6 bags per case, SKU 10071179473015. Packaging Distri

Undeclared wheat. Product contains wheat but was mis-labeled as Savory 6 Cut Crinkle Cut Wedge and label does not declare wheat.

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Lupin Pharmaceuticals Inc. — Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin P

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

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Lupin Pharmaceuticals Inc. — Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

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Lupin Pharmaceuticals Inc. — Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Ph

CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor

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Cipla USA, Inc. — Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Cipla USA, NDC 69097-0936-98

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

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Cipla USA, Inc. — Lanthanum Carbonate Chewable Tablets, 1000mg, 10-count bottle, Rx only, Manufactured for Exelan Pharmaceuticals, NDC 76282-0478-90

Failed Tablet/Capsule Specifications: Complaints received of crushed and broken tablets.

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Taylor Farms Colorado, Inc. — raw, yellow onions (whole peeled), intended for food service, packaged into plastic bags (5-lbs)

Potential contamination of E. coli O157:H7

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Taylor Farms Colorado, Inc. — raw, yellow onions (whole unpeeled), intended for food service, repacked into in 5-lb plastic bags

Potential contamination of E. coli O157:H7

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FreshPoint Denver, Incorporated — Item Number PACK/SZ BRAND DESCRIPTION Lot Codes 082076 4/5 LBS IMPERIALFRESH PROC ONION YELLOW JULIENNE 3/8 All lot codes; 170992 4/5 LB IMPERIALFRESH PROC ONION YELL

Potentially contaminated with E. coli O157:H7.

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Taylor Farms Colorado, Inc. — raw, yellow onions (sliced, diced, slivered, ringed), intended for food service, packaged in plastic bags

Potential contamination of E. coli O157:H7

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Taylor Farms Colorado, Inc. — raw, yellow onions (whole unpeeled), intended for food service, in 50-lb corrugated boxes

Potential contamination of E. coli O157:H7

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FreshPoint Denver, Incorporated — 154784 1 / 5LB IMPERIALFRESH PROC FAJITA GRN PEPRED PEP W All lot codes

Potentially contaminated with E. coli O157:H7.

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Acme Smoked Fish Corp. — KIRKLAND Signature Smoked Salmon NET WT 340 g (12 oz) MUST KEEP REFRIGERATED. INGREDIENTS: Atlantic Salmon (Salmo Salar), Salt, and Natural Hardwood Smoke. Color Added. Distri

The firm was notified after laboratory analysis that the product test positive for Listeria monocytogenes.

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