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All recalls8,521 total

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Denver Solutions, LLC DBA Leiters Health — Rocuronium Bromide 50 mg per 5mL (10mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC: 71449-004-11

Lack of Assurance of Sterility: Leaking/damaged syringes.

M
Medisca Inc. — Bimatoprost powder, Bulk Ingredient, a) 5g (NDC 38779-3066-03), b) 1g (NDC 38779-3066-06), c) 1g (NDC 38779-3066-09) drums, Medisca, Plattsburgh, NY

CGMP Deviations

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Denver Solutions, LLC DBA Leiters Health — dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compar

Lack of Assurance of Sterility: Leaking/damaged syringes.

B
B. Braun Medical Inc — 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-

Presence of Particulate Matter

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Denver Solutions, LLC DBA Leiters Health — Glycopyrrolate, 1mg per 5mL, (0.2 mg/mL), Single Dose 5 mL syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112. NDC 71449-104-11

Lack of Assurance of Sterility: Leaking/damaged syringes.

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Denver Solutions, LLC DBA Leiters Health — Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11

Lack of Assurance of Sterility: Leaking/damaged syringes.

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Denver Solutions, LLC DBA Leiters Health — PHENYLephrine HCl in 0.9% Sodium Chloride, 0.5 mg per 5mL (100 mcg/mL), 5 mL Single Dose Syringe, Rx Only, Leiters Health, 13796 Compark Blvd, Englewood, CO

Lack of Assurance of Sterility: Leaking/damaged syringes.

K
Knockroe Inc — Bonya Raspberry Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Peach Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Passion Fruit Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate

Undeclared Almonds

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Knockroe Inc — Bonya Lemon Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Pineapple Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Black Cherry Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Coconut Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Reser's Fine Foods, Inc. — Trader Joe's Hot Honey Mustard Dressing (SKU #80152), packaged in glass bottle with tamper overwrap on plastic cap, net wt. 12 fl. oz. UPC 0080 1522. DIST. & SOLD Exclusivel

Undeclared peanuts, soy, sesame, and wheat.

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Knockroe Inc — Bonya Strawberry Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Blueberry Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Mango Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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Knockroe Inc — Bonya Vanilla Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrigerate .

Undeclared Almonds

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NRC Nutrition Pty Ltd — Preconception Multi for Women 60 capsules packaged in blister packs Batch 42469

inconsistent blending of iodine in the product

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Knockroe Inc — Bonya Strawberry-Banana Yogurt Parfait, 8oz, Plastic cups with plastic inserts for granola, 6 units per case for distributors, 12 units per case for all other customers, Always Refrige

Undeclared Almonds

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Walker's Fruit Basket and Press House — Walker's Wine Juice Pumpkin Juice 2.5, 5, 30, 60, 275 gallon bulk containers

May be contaminated with Clostridium botulinum

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Craftmark Bakery, LLC — 5000108 OATMEAL RAISIN COOKIE DOUGH, 6 poly bags of 30 frozen pucks in a corrugate case, Net Weight: 8.67 kg (19.12 lb)

Potential contamination with foreign material (plastic)

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Craftmark Bakery, LLC — 5000642 CraftMark Oatmeal Cranberry Raisin Cookie Dough, 8 poly bags of 18 frozen pucks in a corrugate case, Net Weight 27.00 lb

Potential contamination with foreign material (plastic)

C
Craftmark Bakery, LLC — US Foods PREMIUM MONSTER COOKIE, 3 0Z Individually Poly film wrapped Ready to eat cookies, UPC 7 67367 10341 5. 52 Individually Poly film wrapped Ready to eat cookies per cas

Potential contamination with foreign material (plastic)

C
Cromer Food Services, Inc — CFS CROMER FOOD SERVICES, INC. Anderson, SC 29621 CHICKEN SALAD On White NET WT. 4.3 OZ CONTAINS: EGGS, WHEAT, SOY UPC 31166 & UPC 13172

Undeclared Milk - During an FDA inspection the firm was notified that milk was not declared on the label.

F
Frito-Lay, Inc. Headquarters — Tostitos Cantina Traditional Yellow Corn Tortilla Chips. Net Wt. 13oz. (368.5) UPC 0 28400-52848 1. Frito-Lay, Inc., Plano, TX 75024-4099.

Undeclared allergen (milk).

A
AGRI-MARK INC — Cabot Creamery 8oz Extra Creamy Premium Butter, Sea Salted. Packaged as (2) 4oz sticks in cardboard shells; UPC: 0 78354 62038 0

Product contaminated with elevated levels of coliform.

T
The Truck Farm, LLC — Desert Farms Jalapeno Mustard. Caution to refrigerate after opening. The shelf life is 2 years after the date of manufacture. It is packaged in 8 oz glass jars with a net wt. of

The product is in violation for not having an approved filed process and for not having monitoring records.

B
Breckenridge Pharmaceutical, Inc. — Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Sp

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

C
Chattem Inc — Unisom, SleepMinis, Diphenhydramine HCl, Mini-Capsules, 25 mg, 60 Mini-Capsules bottles, Dist. by Chattem, Inc., P.O. Box 2219, Chattanooga, TN 37409-0219, USA, UPC 0 41167 00670 2

CGMP Deviations; detection of Nitrosamine Drug Substance-Related Impurities (NDSRI), N-nitroso-desmethyl-diphenhydramine (n-dph), above the FDA Recommended Intake Limit

N
Nader Trading, Inc. — Kashk (Whey) Ingredients: Whey, Water, Salt Nader Trading Inc., 1821 E. Dryer Road, Santa Ana, CA 92705 UPC# 685357001537

Finished product label fails to include Milk in ingredient listing. (Undeclared Allergen)

M
MTN OPS, LLC — MTN OPS MULTI-V Men's Daily Multivitamin dietary supplement, 60 Capsule Bottle (30 Serving). Manufactured exclusively for MTN OPS, LLC, 251 S Mountain Rd., Fruit Heights, UT. UPC 8 403

Undeclared soy flour

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OLD WORLD SPICES & SEASONING, INC — Lillie's Q Buffalo Wing Sauce. Net wt. 13.5 oz, UPC 810069510972, Case label: Lillie's Q Buffalo Wing Sauce, Item # FGLOL422 Lot # 002125, 6/13.5 oz, UPC 1081006951

Undeclared allergen (milk not listed as sub ingredient of butter). Milk also not listed in 'Contains' statement.

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Falafel King Enterprises, Inc. — Falafel King Taste the Mediterranean is a multi-component, 4 section plastic container, that includes Traditional Hummus, Falafel Balls, Tzatziki, and Mixed Vegetables

Label declares tahini paste but does not declare sesame.

S
Sanders Candy Factory Inc — Frosted Almond; 20 lbs (bulk); No UPC# Bulk Product Code: 23208

elevated levels of aflatoxin

A
Amerisource Health Services LLC — Voriconazole Tablets, 50 mg, packaged in cartons of 3 blister cards with 10 individual blistered doses (30 Unit Dose per carton), Rx only, Distributed by: American He

cGMP Deviations: Received notification from their supplier requesting they perform a recall due to the fact they repackaged the product.

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RemedyRepack Inc. — Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC; 70518-3772-00

CGMP Deviations

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Barry Callebaut USA LLC — CACAO BARRY Gianduja Noir, 5.5lbs (2.5kg) plastic bucket, 8 buckets per case.

Undeclared milk

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Bioriginal Food & Science Corporation — Fresh Flax Oil OMEGA 3-6-9 Organic Flaxseed Oil 16 Fl oz / 473 ml, Dietary Supplement, Black HDPE plastic bottle with cap, Manufactured for Natural Slim, San Ju

Undeclared allergens: Soy lecithin

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Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka India, Manufactured for: BluePo

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Zydus Pharmaceuticals (USA) Inc — Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 0

Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.

S
Somerset Therapeutics Private Limited — Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 7

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection, 100 mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-383-10

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-381-01 (indi

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Somerset Therapeutics Private Limited — Haloperidol Decanoate Injection 100mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited, Kamataka, India, Manufactured for: Blue

Lack of Assurance of Sterility: Media fill with bacterial contamination

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Phasor Health, LLC — Phasor Drill, REF: 2.70S, 3.20L, 4.50, 5.30, 6.35

Drill for use in neurosurgical procedures may have a reverse battery orientation, which may increase surgical time.

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The Coastal Companies DBA Hearn Kirkwood — Turkey BLT on Sourdough Net Wt. 8.94 OZ (253g) in plastic clamshell

Turkey BLT on Sourdough Sandwiches being recalled due to the product having the incorrect sandwich (Peanut Butter & Jelly) in the clamshell container. This incorrect product in the container resulted in an undeclared allergen on the product label (peanuts).

D
Dessert Holdings Llc — favorite day gourmet New York-Style CHEESECAKE 2 SLICES NET WT 6OZ (170 g) UPC 0 85239 09690 1 Target Brands, Inc.

Undeclared Pecan. The firm was notified by their customer that when they were placing the product on the shelves, they noticed the wrong product was in the container.

H
Harvey Investments LLC / The Baking Group — Brioche Bread Loaf and Hamburger buns packaged in brown box and labeled as follows: 1. Ben E. Keith Co. Dense Brioche Pullman Loaf, 33 oz. 7 Count, Case

Undeclared allergens (soy, milk) and Yellow #5

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