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All recalls8,436 total

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KENIL HEALTHCARE PRIVATE LIMITED — Kingskin, SacaCallos, 17% Salicylic acid, 0.5 fl oz (14.8mL) Bottle, Dist. by: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-423-15, UPC 8 10096 7716

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Artridon Glucosamine (menthol 2% and Methyl Salicylate 15% - Topical Analgesic), for arthritis joint pain relief, 5 oz (142g) Tube, Dist by/por: Pharmadel LLC, New C

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Rapidol Maximum Strength, Hydrocortisone 1% Anti-Itch Cream, NET WT 2 oz (60g) Tube, Distributed by: Pharmadel LLC, New Castle, DE, 19720, NDC 55758-420-02, UPC 8 10

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 4.6 OZ (130 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Va

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.85 oz (24 g) Tube, Made in India, Dist. by Bob Barker Co. Inc. Fuquay

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Maximum Security, Anticavity Gel Toothpaste, Sodium Fluoride 0.22%, Fresh Mint Flavor, NET WT 0.15 OZ (4.25 g) Sachets, Made in India, Dist. by Bob Barker Co. Inc.,

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 0.6 OZ (17g) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Varina,

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Nature Mint, Anticavity Fluoride Toothpaste, Sodium monofluorophosphate 0.76%, NET WT 6.4 OZ (181 grams) Box, Made in India, Dist. by Bob Barker Co. Inc., Fuquay-Var

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — CURA HONGOS, Antifungal Cream, Clotrimazole 1%, Net Wt/ Peso Neto 2 oz (56.7g) Tube, Distributed by: Pharmadel LLC, New Castle, DE 19720, Made in India, UPC 8 997110

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — KOFAL Original, Penetrating Pain Relieving Ointment (methyl salicylate 12% - Topical Analgesic), 4 oz (113 g) Jar, Distributed by: Pharmadel LLC, Georgetown, DE 1997

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc/ Neomycin Sulfate/ Polymyxin B Sulfate, Net Wt 2 oz (56g) Tube, Distributed by: Pharmadel LLC, New Cas

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — KOFAL, Athletes, Penetrating Pain Relief, External Analgesic Ointment (methyl salicylate 10.5% - External Analgesic), 2 oz (60 g) Jar, Distributed by: Pharmadel LLC,

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — Cinnafresh anticavity gel toothpaste, sodium fluoride 0.22%, Bold Cinnamon Flavor, NET WT. 0.85 OZ (24 grams) Tube, Made in India, Dist. by Bob Barker Co. Inc., Fuqu

CGMP Deviations

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KENIL HEALTHCARE PRIVATE LIMITED — CURA HONGOS, Antifungal, 1% Clotrimazole, Topical Lotion, 0.76 fl oz (22.5 mL) Bottle, Dist by/por: Pharmadel LLC, New Castle, DE 19720, Made in India, NDC 55758-34-

CGMP Deviations

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Better Business...Better Foods, Inc. — New England Village Snacks The 19th Hole Snack Mix (5 oz. and 10 oz.)

Contains undeclared almonds & undeclared sesame

N
NEW GRAINS GLUTEN FREE BAKERY — Cinnamon Raisin Bagels: Gluten-free cinnamon raisin bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg whites, Raisins, Hone

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Frosted Sugar Cookie: Gluten-free frosted sugar cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: White rice flour, Powdered sugar, Butter, Sugar, Palm

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

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NEW GRAINS GLUTEN FREE BAKERY — Multigrain Bagels: Gluten-free multigrain bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg whites, Tapioca flour, Honey, G

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Artisan Cinnamon Raisin Bread: Gluten-free cinnamon raisin bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Egg whites,

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Artisan White Bread: Gluten-free artisan white bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Egg whites, Tapioca flo

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Dye-Free Frosted Sugar Cookie: Gluten-free dye-free frosted sugar cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: White rice flour, Powdered sugar, B

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

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NEW GRAINS GLUTEN FREE BAKERY — Brownie Chocolate Chip Cookie: Gluten-free brownie chocolate chip cookies, clear plastic bag, 4 oz, 8 cookies/package Ingredients: Sugar, Eggs, Butter, Chocolate chip

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

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NEW GRAINS GLUTEN FREE BAKERY — Artisan Multigrain Bread: Gluten-free multigrain bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Egg whites, Tapioca f

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Coconut Macaroon Cookie: Gluten-free coconut macaroon cookies, clear plastic bag, 4 oz, 6 cookies/package Ingredients: Coconut flakes, Sweetened condensed milk, Egg w

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

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NEW GRAINS GLUTEN FREE BAKERY — Plain Bagels: Gluten-free plain bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg whites, Tapioca flour, Sugar, Palm fruit

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Artisan Sourdough Bread: Gluten-free sourdough bread, vacuum-sealed clear plastic, 32 oz, 1 loaf/package Ingredients: White rice flour, Water, Eggs, Tapioca flour, Su

Due to printing quality, label does not declare Egg allergen clearly.

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NEW GRAINS GLUTEN FREE BAKERY — Seasoned Bread Crumbs: Gluten-free seasoned bread crumbs, vacuum-sealed clear plastic, 8 oz, bulk Ingredients: White rice flour, Water, Egg, Golden flax seed, Rice br

Due to printing quality, label does not declare these allergens clearly: Egg and Milk.

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East CK Trading Inc. — PRESIDENT BRAND; Kumquat Slices; NET WT. 8 OZ/227g; EAST CK TRADING INC.; INGREDIENTS: Kumquat slices; packaged in clear plastic jars with UPC 8 10077 20936 3

Product contains undeclared sulfites (7.49mg/serving)

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NEW GRAINS GLUTEN FREE BAKERY — Pecan Caramel Bars Individually wrapped in plastic. Ingredients: White rice flour, Sugar, Honey, Pecan pieces, Butter, Eggs, Rice milk, Potato flour, Vanilla, Baking p

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Pecan.

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NEW GRAINS GLUTEN FREE BAKERY — Artisan Seasoned Croutons: Gluten-free artisan seasoned croutons, vacuum-sealed clear plastic, 8 oz, bulk Ingredients: White rice flour, Water, Egg, Golden flax seed,

Due to printing quality, label does not declare these allergens clearly: Egg and Milk.

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NEW GRAINS GLUTEN FREE BAKERY — Chocolate Chip Cookie: Gluten-free brownie chocolate chip cookies, clear plastic bag, 4 oz, 8 cookies/package Ingredients: White rice flour, Butter, Chocolate chips,

Due to printing quality, label does not declare these allergens clearly: Egg, Milk, Soy.

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NEW GRAINS GLUTEN FREE BAKERY — Blueberry Bagels: : Gluten-free blueberry bagels, clear plastic bag, 16 oz, 4 bagels/package Ingredients: White rice flour, Water, Egg whites, Tapioca flour, Sugar, P

Due to printing quality, label does not declare Egg allergen clearly.

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BRS Analytical Services, LLC — Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle,

cGMP deviations and lack of assurance of sterility.

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BRS Analytical Services, LLC — Carboxymethylcellulose Sodium Ophthalmic Gel 1%, Carboxymethlycellulose Sodium 1% Eye Lubricant, Lubricant Eye Gel, Soothing Gel, Sterile, 0.5 FL OZ (15mL) per bottle, D

cGMP deviations and lack of assurance of sterility.

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BRS Analytical Services, LLC — Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, N

cGMP deviations and lack of assurance of sterility.

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BRS Analytical Services, LLC — Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15m

cGMP deviations and lack of assurance of sterility.

B
BRS Analytical Services, LLC — Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Carboxymethlycellulose Sodium 0.5% Eye Lubricant, Lubricating Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL)

cGMP deviations and lack of assurance of sterility.

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RemedyRePack Inc. — Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701. NDC#: 70518-3772-02

CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets.

3
3M Company — 3M Ranger Irrigation Fluid Warming Set, REF 24750

Notice was issued to clarify flow rates related to the inlet fluid temperature.

J
JJWV Marketing Corporation — Ankimo branded Monkfish Liver; NET WT. 7 OZ (200g); Imported and DIST. BY: JJWV Marketing Corporation; Santa Fe Springs, CA 90670 USA; UPC# 8 94042 00256 2

Undeclared allergen ingredient (milk)

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Eugia US LLC — Tirofiban Hydrochloride Injection 12.5 mg/250 mL (50 mcg/mL), 250 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Wi

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

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Eugia US LLC — Tirofiban Hydrochloride Injection 5 mg/100 mL (50 mcg/mL), 100 mL single-dose container (bag), Rx only, Manufactured in India for: Eugia U.S. LLC, 279 Princeton-Hightstown Rd., E. Winds

Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.

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Mckesson Medical-Surgical Inc. Corporate Office — EVENITY, (romosozumab -aqqg) injection, 105mg/1.17 mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 5

CGMP Deviations; potential temperature excursions due to transit delays

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Mckesson Medical-Surgical Inc. Corporate Office — BENLYSTA (belimumab) for injection, 400 mg/20 mL vial, Rx only, NDC 49401-102-01, GSK.

CGMP Deviations; potential temperature excursions due to transit delays

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Mckesson Medical-Surgical Inc. Corporate Office — PROLIA (denosumab), injection, 60mg/mL, For Subcutaneous Use Only, Rx Only, Manufactured by: Amgen Inc., Thousand Oaks, CA 91320, NDC 55513-710-21

CGMP Deviations; potential temperature excursions due to transit delays

C
Capnia Inc — Precision Sampling Set, REF: C20206 for use with the CoSense End-Tidal Carbon Monoxide Monitor

Sampling set nasal cannula used with End-Tidal Carbon Monoxide (ETCO) monitor may have residual carbon monoxide and volatile organic compounds present due to insufficient aeration of the cannula's carbon filter prior to sealing, which may lead to higher than expected ETOCc scores during clinical evaluations.

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LAMB WESTON Inc — Item M0053, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN* 50195500004896. Made in USA.

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

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LAMB WESTON Inc — Item M7422, frozen foodservice Lamb Weston Hashbrown Patties LW Formed Oval 6/3.5LB bags per case. GTIN*10044979922687. Made in USA.

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

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LAMB WESTON Inc — Item M7414, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN*10044979923820. Made in USA.

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

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LAMB WESTON Inc — Item M7204, frozen foodservice Lamb Weston Hashbrown Patties, frozen, LW Formed Oval 6/3.5LB bags per case. GTIN*10044979923813. Made in USA.

Approximately 1mm to 8 mm sized pieces of foreign material (plastic) found in product.

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