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All recalls7,877 total

H
HARDIES FRESH FOODS — 14019 Cucumber Select 6 CT, 01034 Cucumber Select 5# packaged in polybags Dairyland Produce, LLC

Cucumbers have the potential to be contaminated with Salmonella

B
Bazzini LLC — NuGo Dark Pretzel/Chocolate Chip Multipack 18 ct., 50g bar, 18 bars/tray, 9 trays/case. 40case/pallet

The product is being recalled because of undeclared milk .

B
Bazzini LLC — NuGo Dark Chocolate Pretzel with Sea Salt , Real Dark Chocolate / Vegan. 12g Protein

The product is being recalled because of undeclared milk .

B
Bazzini LLC — NuGo Dark Chocolate Chip, Real Dark Chocolate / Vegan. 12g Protein

The product is being recalled because of undeclared milk .

D
Dairyland Produce, LLC — Texas Harvest Product: 01035 Cucumber Sliced 5# 5-pound trays with sealed film

Cucumbers have the potential to be contaminated with Salmonella.

A
AvKARE — Cinacalcet Tablets, 60 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-460-30

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

A
AvKARE — Cinacalcet Tablets, 90 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-461-30

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

A
AvKARE — Cinacalcet Tablets, 30 mg, 30-count bottle, Rx only, Manufactured for: AvKARE, Pulaski, TN 38478, NDC 42291-459-30

CGMP deviations: Presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Cinacalcet above acceptable intake limit.

H
Handsome Brook Farms, LLC — Kirkland Signature ORGANIC EGGS PASTURE-RAISED 24 EGGS, GRADE A LARGE, NET WEIGHT 48OZ (3 LB) 1.36 kg, UPC 0 96619 10680 6, DISTRIBUTED BY: COSTCO WHOLESALE CORPORATION 730

Eggs from a positive Salmonella environment were shipped into distribution to retail facilities.

S
SunFed Produce, Inc. — Raw cucumbers packaged in cardboard boxes or plastic boxes (RPC) with "SunFed", "Vegetables", or "Agrotato" labeling. 1 1/9 BU CAS Super Slicer Cucumber/10814780010749 1 1/9 B

Cucumbers potentially contaminated with Salmonella.

C
Curium US, LLC — Kit for the Preparation of Technetium Tc 99m Sestamibi Injection, Each Kit contains: 30 sterile and non-pyrogenic reaction vials each containing Tetrakis (2-methoxy isobutyl isonitril

Lack of Assurance of Sterility; Improper crimps on vials impacting the integrity of the product

S
SE Tampa Inc dba Tampa Food — Crab Cheese Rangoon, NET WT: 8 LB, 120 pieces of 30g / 3 Trays per master cardboard boxes, Keep Frozen, packaged in corrugated cardboard box.

Undeclared allergens: Milk, Soy, Crustacea Shellfish, Fish

M
Macleods Pharmaceuticals Ltd — Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods Pharma USA Inc. Pri

Failed Impurities/Degradation Specifications

P
Provepharm Inc. — Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Ampules, Rx Only, Distributed by: Provepharm Inc. 100 Springhouse Drive Suite 105, Collegeville, PA 19426,

Discoloration

G
Generitech Corporation — 10 Irregular Pigmentation, Accelerator, Pigment Fading Activator, Only Your Rx, Nature + Science, 1 fl. oz., 30 mL Bottle, For Professional Use Only, Only YourRx Inc., Chatswo

CGMP Deviations: Inconsistency in the water systems.

D
Dr. Reddy's Laboratories, Inc. — Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435

Failed Impurities/Degradation Specifications

A
Apothecus Pharmaceutical Corp. — VCF, Vaginal Contraceptive Gel, Birth Control, 10 Pre-filled Applicators, Net Wt. 0.09 oz (2.55g) Each, Distributed By: Apothecus Pharmaceutical Corp., Ronkonkoma, NY

CGMP deviations: out of specifications for assay

J
Jubilant Draximage Inc., dba Jubilant Radiopharma — Kit for the Preparation of Technetium Tc 99m Sulfur Colloid Injection, 10 mL Multi-Dose Reaction Vial, 5 vial Box, Rx Only, Manufactured for: Jubila

Failed Stability Specifications

S
SUGAR FOODS LLC — Fresh Gourmet TORTILLA STRIPS SANTA FE SYTLE NET WT 3.5 OZ (99g) UPC 7 87359 17504 6 DISTRIBUTED BY: FRESH GOURMET CO. WESTLAKE VILLAGE, CA 91361

Undeclared Wheat. The firm was notified by a consumer that they found crispy onions in the packaging of the tortilla strips. The onions contain wheat which is not listed on the packaging for the tortilla strips.

J
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's — Mama Mancini s Stuffed Shells with Sauce and Mozzarella Cheese, 4 packs of 4 lbs. each / 6 packs of 14 oz. each, 4 packs/boxes per case / 6 pl

Products have the potential to be contaminated with Listeria monocytogenes.

J
Joseph Epstein Food Enterprises, Inc. dba MamaMancini's — Hungryroot Ricotta Stuffed Shells, 6 packs of 14 oz. each, plastic trays

Products have the potential to be contaminated with Listeria monocytogenes.

M
Michael Zakany LLC — Jose Madrid Salsa Chipotle Con Queso, Net Wt. 13 oz. (369g), packaged in glass jars; 12 jars per case

Undeclared Yellow #5 and Yellow #6

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutical

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 150 mcg (0.150 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

M
Mylan Institutional, Inc. — Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), 100 Tablets per carton (10 unit dose blister cards of 10 tablets each), Rx only, Manufactured for: Mylan Pharmaceutic

Subpotent and Superpotent Drug

R
Rising Pharma Holding, Inc. — Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharma

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

R
Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Dist

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

R
Rising Pharma Holding, Inc. — Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

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

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Carrots. Bulk 1 pound bags. Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Commerce, CA 92022 USA

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Vegetable Medley; Broccoli, Carrots & Cauliflower. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUT

potential contamination with E. coli O121:H19

F
F&S Fresh Foods, Inc. — WHOLE FOODS MARKET, Organic Carrots & Celery, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat

Potential contamination with E. coli O121:H19

F
Fabalish, — Fabalish Inc. , Kickin, Carrot Falafel , 10oz , Cardboard tray inside plastic film inside cardboard box, individual units

Potential E Coli contamination.

4
4 Earth Farms formerly Mcl Fresh Inc — Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) (6 pack/case) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED BY: Wa

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Vegetable Medley; Broccoli, Cauliflower, Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 32 OZ (2 LB) 907g DISTRIBUTED BY: Walmart In

potential contamination with E. coli O121:H19

F
F&S Fresh Foods, Inc. — WHOLE FOODS MARKET, Organic Carrot Sticks, NET WT. 15 oz (425 g), PERISHABLE KEEP REFRIGERATED, Packed For: Whole Foods Market Austin, TX 78703, Pre-washed and ready to eat

Potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Stir Fry Medley; Carrots, Broccoli, Broccoli Stem, Stem. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBUTED

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Broccoli Slaw (Salade DE Brocoli), 4Earth Farms, Net Weight/Poids Net (340 g) 12oz (6 pack/case) Washed and ready to prepare, Perishable keep refrigerate

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Vegetable Medley; Broccoli, Cauliflower, & Carrots. Washed and ready to prepare; Perishable keep refrigerated. NET WT 12 OZ (340g) (6 pack/case) DISTRIBU

potential contamination with E. coli O121:H19

4
4 Earth Farms formerly Mcl Fresh Inc — Organic Broccoli Medley, 4Earth Farms, Net Weight 12 oz (340 g) Washed and ready to prepare, Perishable keep refrigerated. Distributed by 4Earth Farms, LLC., Com

potential contamination with E. coli O121:H19

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 150 mcg, packaged in a) 90-count bottles (NDC 0378-1815-77) and b) 1000-count bottles (NDC 0378-1815-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 100 mcg, packaged in a) 90-count bottles (NDC 0378-1809-77) and b) 1000-count bottles (NDC 0378-1809-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 50 mcg, packaged in a) 90-count bottles (NDC 0378-1803-77) and b) 1000-count bottles (NDC 0378-1803-10), Rx only, Manufactured for: Mylan Pharmaceutical

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 125 mcg, packaged in a) 90-count bottles (NDC 0378-1813-77) and b) 1000-count bottles (NDC 0378-1813-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 200 mcg, packaged in a) 90-count bottles (NDC 0378-1819-77) and b) 1000-count bottles (NDC 0378-1819-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (NDC 0378-1811-77) and b) 1000-count bottles (NDC 0378-1811-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

V
Viatris Inc — Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (NDC 0378-1817-77) and b) 1000-count bottles (NDC 0378-1817-10), Rx only, Manufactured for: Mylan Pharmaceutica

Superpotent Drug and Subpotent Drug: potency failures obtained

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