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All recalls7,819 total

G
GET TESTED INTERNATIONAL AB — Chlamydia Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Gonorrhea test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Cholesterol Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Iron Deficiency Test (ferritin)

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Thyroid TSH Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Herpes (HSV-1 & HSV-2) Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Iron Deficiency Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Diabetes Test (ketones & glucose)

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Liver Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Pregnancy Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Allergy & Food Intolerance Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Ovulation Test (5 tests)

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Food Sensitivity Test Medium

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Men s Hormone Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — H pylori (Peptic ulcer) Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Neurotransmitters Basic

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Epstein-Barr Virus (EBV VCA & EBNA IgG) Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Fecal Occult Blood Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Women s Hormone Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Melatonin Test

Distribution without premarket approval/clearance.

O
Orthofix U.S. LLC — Brand Name: FIREBIRD" SI Fusion System Product Name: FIREBIRD" SI Fusion System Model/Catalog Number: 18-1025SP 11mm X 25mm FIREBIRD SI Screw; 18-1030SP 11mm X 30mm FIREBIRD SI

Labeling contains claims that are not consistently present.

G
GET TESTED INTERNATIONAL AB — Neurotransmitters XL

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — IBS Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Sorbitol Intolerance Test

Distribution without premarket approval/clearance.

O
Orthofix U.S. LLC — Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0¿, 9W x 23L x 7H 38-1008SP FORZA PTC Spa

Labeling contains claims that are not consistently present.

G
GET TESTED INTERNATIONAL AB — Environmental Pollutants Profile Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Vaginal PH Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Gut Microbiome Test Medium

Distribution without premarket approval/clearance.

O
Orthofix U.S. LLC — Brand Name: Pillar" SA PTC Spacer System Product Name: Pillar" SA PTC Spacer System Model/Catalog Number: 39-9012SP 33W X 28L X 12.5H, 7DEG PTC IMPLANT; 39-9014SP 33W X 28L X 14

Labeling contains claims that are not consistently present.

G
GET TESTED INTERNATIONAL AB — Estrogen & Progesterone Test

Distribution without premarket approval/clearance.

G
GET TESTED INTERNATIONAL AB — Continuous Glucose Monitor (CGM)

Distribution without premarket approval/clearance.

M
Medtronic MiniMed, Inc. — MiniMed 780G Insulin Pump Catalog Numbers: MMT-1884 MMT-1886 With Software Version 6.60 The MiniMed 780G insulin pump is indicated for use by patients age 7-80 years wi

A software timing and processor communication issue in MiniMed" 780G software version 6.60 may trigger Pump Error 43 and/or Pump Error 41, resulting in suspension of insulin delivery.

H
HANA GROUP — Mai California Roll WR - UPC 840031402639 5.9 oz (167g) Plastic tray with plastic lid

Wheat and Soy missing allergens from the product Contains Statement.

B
Blonde Beard's — Blonde Beard's Dojo Asian Wing Sauce, wing sauce hot sauce condiment, shelf stable, 2 years, glass bottle, 8 oz, Blonde Beard s. Responsible firm on label: Blonde Beard s 2230 S Brau

Undeclared Soy

B
BULK & ORGANIC LLC — Bulk and Organic Organic Moringa Powder, 44.1lbs bag

Possible Salmonella Richmond

F
First & Last Tavern — First & Last Tavern Marinara Sauce (tomato & basil) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

F
First & Last Tavern — First & Last Tavern Puttanesca Sauce (olives, capers, hot peppers) 26 FL OZ (1 lb, 10 oz) 737g

May be contaminated with Clostridium botulinum

I
INDIAN COOKWARE AND APPLIANCE LLC — ALUMINIUM HAMMERED KADAI SIZE 7 8 901000 000057 MADE IN INDIA

Potential contamination due to leachable lead.

F
First & Last Tavern — First & Last Tavern Traditional Pasta Sauce (meat flavored) 26 FL OZ (1 lb., 10 oz) 737g

May be contaminated with Clostridium botulinum

B
Blossom Pharmaceuticals — Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauder

cGMP deviations

B
Blossom Pharmaceuticals — Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacram

cGMP deviations

B
Blossom Pharmaceuticals — Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.

cGMP deviations

B
Blossom Pharmaceuticals — Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — Benco dental Graham CHEMICAL CO., Mepivacaine HCI 3% (30 mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Car

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — darby dental supply, MEPIVACAINE, Mepivacaine HCI 3% (30mg/mL) Injection, [Mepivacaine HCI Injection, USP], packaged in a carton containing 50 single-dose Car

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.

cGMP deviations

N
Novocol Pharmaceutical of Canada, Inc. — 3% Polocaine DENTAL, Mepivacaine Hydrochloride 3% (30mg/mL) (Mepivacaine HCI Injection, USP), packaged in a carton containing 50 single-dose Cartridges, 1.7 ml

Defective container: cracked/broken cartridges

B
Blossom Pharmaceuticals — Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.

cGMP deviations

C
Cipla Limited — Phytonadione Injectable Emulsion, USP 10mg/mL, 10x1 mL Single-Dose Vial/carton, Rx Only, Mfd. by: Cipla Ltd. India At M/s Immacule Lifesciences PVT. Ltd. India. Mfd. for: Cipla USA, In

Failed Stability Specifications: Observed OOS results: eg results for colour index

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