FDA daily for Monday, April 13, 2026
In this issue: 32 approvals, 19 device recalls, 13 device decisions and 162 label changes. 1 item touches categories MedGrid carries, and it comes first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
Drug and biologic approvals
FDA date:On Mon, Apr 6 FDA approved 27 new applications (0 brand or biologic, 27 generic) and 5 supplements to existing ones.
- DAPAGLIFLOZIN
SANDOZ · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
AUROBINDO PHARMA · DAPAGLIFLOZIN
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
MICRO LABS · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- DAPAGLIFLOZIN
MICRO LABS · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
BIOCON PHARMA · DAPAGLIFLOZIN
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
MSN · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- DAPAGLIFLOZIN
MSN · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
AJANTA PHARMA LTD · DAPAGLIFLOZIN
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
SUN PHARM · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- DAPAGLIFLOZIN AND METFORMIN HYDROCHLORIDE
AUROBINDO PHARMA · DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE, DAPAGLIFLOZIN, METFORMIN HYDROCHLORIDE
- DAPAGLIFLOZIN
INVENTIA · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
MACLEODS PHARMS · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
AIZANT · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
LUPIN · DAPAGLIFLOZIN
- DAPAGLIFLOZIN
CIPLA · DAPAGLIFLOZIN
Device recalls
FDA date:FDA posted 19 device recalls from 2 firms on Mon, Apr 6.
- See Luer Cap Set, MPC-130, set, administration, intravascular
Molded Products Inc · Molded Products, Inc. is voluntarily conducting a medical device recall of the MPC-130 See Luer Cap Set based on a confirmed complaint of the threaded sleeve n…
- COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Arterial Pressure Monitoring Tray, Reference Part Number APMY-2.5-15-0-2.5 , Order Number G58412; Reference Part Number APMY-4…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-HC-G-EU, Order Number G57685; R…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Blue Rhino G2-Multi Percutaneous Tracheostomy Introducer Tray: Reference Part Number C-PTISY-100-HC-G-NA, Order Number G57703;…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Ciaglia Blue Rhino Percutaneous Tracheostomy Introducer Set: Reference Part Number C-PTIS-100-FLEX-HC, Order Number G32092; Re…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Cook Staged Extubation Set: Reference Part Number C-CAE-14.0-83-EXTU, Order Number G24073
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Cook Spectrum Central Venous Catheter Tray: Reference Part Number C-UTLMY-701J-ABRM-CUSTOM-0003, Order Number G56424; Referenc…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- COOK MEDICAL Cook Strange Bile Duct Stone Exploration Set: Reference Part Number C-CSRC-7.5D-40-STRANGE, Order Number G09108
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
- Melker Universal Cuffed Emergency Cricothyrotomy Catheter Set: Reference Part Number C-TCCSB-500-UNI, Order Number G32193; Reference Part N…
Cook Incorporated · Products from the affected device lots were labeled with expiration dates that exceed the true shelf life.
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 3 PMA decisions on Mon, Mar 30.
- AiORTA - Plan v2.0
ViTAA Medical Solutions, Inc. · Radiology
- Sagami Original 002 Polyurethane Male Condom
Mayer Laboratories · Obstetrics/Gynecology
- FLOW FLEXTEND Wand (72290039)
ArthroCare Corporation · General, Plastic Surgery
- implantcast Packaging System Update
Implantcast GmbH · Orthopedic
- Francisella tularensis Real-time PCR Assay
Centers for Disease Control and Prevention · Immunology
- IntelliVue Measurement Rack 6000 (867317)
Philips Medizin Systeme Böblingen GmbH · Cardiovascular
- Spectrum Spine Cervical Cage System; Spectrum Spine Lumbar Cage System
Spectrum Spine · Orthopedic
- FINDER Flu A&B/SARS-CoV-2 Test
Baebies, Inc. · Microbiology
- Avatar Medical Vision
Avatar Medical · Radiology
- Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Bloomden Bioceramics (HuNan) Co., Ltd. · Dental
Label updates
FDA date:162 drug labels took effect on Mon, Mar 30; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Sertraline
SERTRALINE · Bryant Ranch Prepack · ORAL
- Fluoxetine
FLUOXETINE HYDROCHLORIDE · RADHA PHARMACEUTICALS, INC. · ORAL
- Naproxen
NAPROXEN · Radha Pharmaceuticals, Inc. · ORAL
- Ibuprofen
IBUPROFEN · Bryant Ranch Prepack · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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