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All recalls8,521 total

F
Fresenius Kabi Compounding, LLC — NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-027-58

cGMP violations

F
Fresenius Kabi Compounding, LLC — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-010-58

cGMP violations

F
Fresenius Kabi Compounding, LLC — EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-060-58

cGMP violations

F
Fresenius Kabi Compounding, LLC — Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-028-59

cGMP violations

F
Fresenius Kabi Compounding, LLC — NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-025-58

cGMP violations

F
Fresenius Kabi Compounding, LLC — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-024-58

cGMP violations

D
Denison Pharmaceuticals, LLC — Adult Cough and Chest Congestion (Dextromethorphan HBr USP 20 mg, Guaifenesin USP 400mg), packaged in 4 oz bottles further package in cartons, Distributed by: Genexa I

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

F
Fresenius Kabi Compounding, LLC — Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC: 71506-079-56

cGMP violations

D
Denison Pharmaceuticals, LLC — Kids' Cough and Chest Congestion (Dextromethorphan HBr, USP 5mg/ Guaifenesin, USP 100 mg), packaged in 4 oz bottles further packaged in cartons, Distributed by: Genexa I

Crystallization: Lack of uniformity - a change in texture, chunky, grainy, and small crystal substances inside the bottles.

F
Fresenius Kabi Compounding, LLC — Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-014-58

cGMP violations

F
Fresenius Kabi Compounding, LLC — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-002-58

CGMP violations

F
Fresenius Kabi Compounding, LLC — Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Single Dose Bag, Rx only, Fagron Sterile Services, Canton, MA NDC 71506-029-58

cGMP violations

T
Tropical Nut & Fruit Company — Grabeez The Big Cheese SNACK MIX Net Wt. 3.25 oz (92g) Ingredients: Peanuts***Cheese Pretzel Gems***Vegetable Shortening***Snackin' Mix***Cheez-It Crackers***Cheese Wick

Undeclared Almonds & Cashews. The firm was notified by their customers that the product contains a trail mix instead of the cheese mix. The trail mix contains almonds and cashews that are not listed in the ingredient statement.

N
Nivagen Pharmaceuticals Inc — Atorvastatin Calcium Tablets, USP, 40mg, Rx only, 1000 Tablets per bottle, Manufactured for: Nivagen Pharmaceuticals, Inc. Sacramento, CA 95827, USA, Manufactured by: Ume

Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of Atorvastatin Calcium Tablets, USP 40 mg.

G
Glenmark Pharmaceuticals Inc., USA — Ryaltris (olopatadine hydrochloride and mometasone fluorate) Nasal Spray, 665 mcg/25 mcg per spray, 240 Metered Sprays/bottle, 29 g net fill weight, Distr. by Hikm

Defective Delivery System: The dip tube is clogged causing the spray not to work.

V
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

S
Salt City Baking Company, LLC — Sour Charlie bread, #2092, bag of 6 rolls (net wt. 7oz), 48 mini loaves per case. UPC code 0076011611894. Product was packaged bulk in a clear plastic bag inside a c

Undeclared Wheat flour. Product contains wheat flour but product was sold without the Ingredients Statement.

A
Advanced Accelerator Applications USA, Inc. — Pluvicto, 1000 MBq/mL (27 mCi/mL), lutetium, LU 177, vipivotide tetraxetan injection, Single-dose vial, Sterile, Manufacturer Advanced Accelerator Applica

CGMP deviations

H
HP Hood LLC — Lactaid Lactose Reduced milk 1. 96 oz Lactaid Whole Milk 2. 96 oz Lactaid 2% Milk 3. 96oz Lactaid 1% Milk 4. 96oz Lactaid Fat Free Milk (1607) 5. 96oz Lactaid 2% Calcium Enriched Milk

Milk may contain undeclared almond from almond milk

G
Gilead Sciences, Inc. — Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, Manufactured for: Gilead Sciences, Inc., Foster City, CA 94404, NDC 61958-2901-2

Presence of Particulate Matter: Presence of glass particle.

E
EnviroServe Chemicals Inc. — EnviroClean Hand Sanitizer Gel (isopropyl alcohol 70% v/v), 473 mL (16 fl. oz.) bottles, EnviroServe Chemicals Inc., 603 South Wilson Avenue, Dunn NC, 28334, NDC 76563-301

CGMP deviations

1
123Herbals — Vail-Bon Jie Yang Wan capsules, 30-count bottle, Vall Boon Medical Factory Sdn. Bhd., No 1, Lorong Mengkudu, Taman Mengkudu, 14100 Juru, Malaysia.

Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared dexamethasone and chlorpheniramine.

B
Bionpharma Inc. — Atovaquone Oral Suspension, USP 750 mg/5 mL, 210 mL bottle, Rx only, Distributed by: Bionpharma Inc., Princeton, NJ 08540, NDC # 69452-252-87.

Microbial Contamination of a Non-sterile Product: The product was found to be contaminated with Cohnella bacteria.

T
Today's Frozen Desserts, Inc. — Premium Grapenut Special, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen

Undeclared Yellow 5 & Yellow 6

T
Today's Frozen Desserts, Inc. — Premium Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen

Undeclared Yellow 5 & Yellow 6

T
Today's Frozen Desserts, Inc. — Premium Pistachio Grapenut, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen

Undeclared Yellow 5 & Yellow 6

T
Today's Frozen Desserts, Inc. — Rum Nut Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen

Undeclared Yellow 5 & Yellow 6

T
Today's Frozen Desserts, Inc. — Rum Raisin Ice Cream, packaged in paper and plastic containers in sizes 3 Gallons, half gallons, and quarts. Keep Frozen

Undeclared Yellow 5 & Yellow 6

A
AbbVie Inc. — Refresh P.M., (Mineral Oil 42.5%, White Petrolatum 57.3%) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC code:

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

A
AbbVie Inc. — Refresh LACRI-LUBE, (42.5% Mineral Oil, 57.3% White Petrolatum) Lubricant Eye Ointment, Net wt, 0.12 oz (3.5g) Tube, Distributed by: Allergen, an AbbVie company, Madison, NJ 07940, UPC

Lack of Assurance of Sterility: The impacted lots may contain a breach in the tube seal.

M
Mac & Co — Mini Raspberry Lemon Coffee Cake, net wt. 13.5oz. UPC 8 57297 00745 4. Made with Gluten-Free Ingredients in a Gluten-Friendly Bakery. Macrina Bakery - Kent, WA. Ingredients: CANE SUGAR,

Undeclared walnut and wheat. Mini Squash Harvest Loaf (UPC 8 55324 00505 3) was mis-labeled as Mini Raspberry Lemon Coffee Cake (UPC 8 57297 00745 4) and therefore wheat flour and walnuts are not declared on label.

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse White Pullman Bread 1/2" Sliced 22 OUNCE. 12 unlabeled 22 OUNCE LOAVES per sale unit case, product code 9518. Net Wt. 16lb 8oz.

Undeclared sesame

K
KTM Services, Inc. — Enjoy Premium Coconut Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags

Undeclared allergens; milk

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse Hawaiian Hamburger Buns 4.5" Sliced 3 OUNCE. 6 unlabeled 12CT PKGS per sale unit case, product code 7430. Net Wt. 13lb 8oz.

Undeclared sesame

K
KTM Services, Inc. — Enjoy Premium Taro Cookies packaged in 5.3 oz. foil pouches and 17.7 oz clear bags

Undeclared allergens; milk

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse Texas Toast 3/4" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9519. Net. Wt. 16lbs 8oz.

Undeclared sesame

N
Nuts.com — S'mores Bites, 1 yummy pound, Distributed by Nuts.com, Cranford, NJ, 07016

Undeclared Allergen, milk - a mix-up between the product description and the ingredient list. Milk Chocolate was listed in the product description but was missing from the ingredient list.

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse 100% Whole Wheat Pullman Bread 1/2" Sliced 22 OUNCE loaf. 12 unlabeled loaves per sale unit case, product code 9520, Net Wt. 16lbs. 8oz.

Undeclared sesame

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse Whole Grain White Hot Dog Buns 6" Sliced 2 OUNCE. 12 unlabeled 12CT PKGS per sale unit case, product code 7502. Net. Wt. 18lbs.

Undeclared sesame

P
Perfection Bakeries LLC — Gordon Food Service Hawaiian Pull-Apart Dinner Rolls Unsliced 1.25 Ounce. 10 unlabeled 12CT PKGS per sale unit case, product code 7148. Net. Wt. 9lbs. 6oz.

Undeclared sesame

P
Perfection Bakeries LLC — Aunt Millie s Bakehouse Whole Grain Dinner Rolls 2.5" Sliced 1.34 OUNCE. 8 unlabeled 24CT PKGS per sale unit case, product code 7488. Net. Wt. 16lbs.

Undeclared sesame

O
Olympus Corporation of the Americas — Olympus Cystoscope Outer Sheath; Model/Catalog number: WA22810A;

Product being removed due to incompatibility when used in conjunction with a GreenLight Laser for BPH therapy which could damage the tip of the device.

B
Berkeley Club Beverages, Inc. — Berkeley Springs Water Purified , Berkeley Springs Water Distilled , One Gallons & Five Gallons, Plastic, 6 gallons in one case and1 individual 5 Gallon, Codes 090326,

Product tested positive for coliforms.

L
Lemonland Food Corp — Item FLD1040A, Wild Leeks, distributed in plastic clamshell containers. Net wt. 0.315lb. The H-Mart label declares: Wild Leeks, Sugar, Soy Sauce.

Soy Sauce is declare but Wheat and Fish (Anchovy) are not declared.

L
Lemonland Food Corp — Item FLD1971, Stir Fried Dried Shrimp, distributed in plastic clamshell containers. Net wt. 0.165lb. The H-Mart label declares: Shrimp, Sesame Oil, Soy Sauce, Corn Syrup, Salt

Soy Sauce is declared but Wheat is not declared.

L
Lemonland Food Corp — Item FLD2011, Salted and Seasoned Small Octopus, distributed in plastic clamshell containers, net wt. 0.267lb. The H-Mart label declares: Octopus, Salt, Garlic, Ginger, Red Pepp

Undeclared Fish (Anchovy).

L
Lemonland Food Corp — Item FLD1080A, Seasoned Radish, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Radish, Red Pepper Powder, Malt Syrup, Salt, Anchovy, Su

Undeclared Crustacean (shrimp).

L
Lemonland Food Corp — Item FLD1010A, Seasoned Peanut, distributed in plastic clamshell containers, net wt. 0.365lb. The H-Mart label declares: Peanut, Soy Sauce, Starch, Syrup, Cooking Oil

Soy Sauce is declared but Wheat is not declared.

L
Lemonland Food Corp — Item FLD1000AA, Seasoned Sesame Leaves or Seasoned Perilla Leaves, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares: Sesame Leaves, Red Pe

Undeclared Monosodium Glutamate

L
Lemonland Food Corp — Item FLD1000A, Perilla Leaves in Soybean Paste, distributed in plastic clamshell containers, net wt. 0.315lb. The H-Mart label declares Perilla Leaves, Soybean Paste.

Soybean Paste is declared but Wheat and Sesame Seeds are not declared.

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