FDA daily for Thursday, March 19, 2026
In this issue: 12 approvals, 11 device recalls, 20 device decisions and 161 label changes. 2 items touch categories MedGrid carries, and they come 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.
- Palio Sunscreen Broad Spectrum SPF 30
AVOBENZONE, HOMOSALATE, OCTISALATE · Sole Palio LLC · TOPICAL
Drug and biologic approvals
FDA date:On Thu, Mar 12 FDA approved 2 new applications (0 brand or biologic, 2 generic) and 10 supplements to existing ones.
- PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
HETERO LABS LTD III · DEXTROMETHORPHAN HYDROBROMIDE, PROMETHAZINE HYDROCHLORIDE
- POTASSIUM PHOSPHATES
CAPLIN · POTASSIUM PHOSPHATE, DIBASIC, POTASSIUM PHOSPHATE, MONOBASIC
Device recalls
FDA date:FDA posted 11 device recalls from 4 firms on Thu, Mar 12.
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRU…
Trividia Health, Inc. · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code descriptio…
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Description/Item: TRUE METRIX…
Trividia Health, Inc. · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code descriptio…
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRU…
Trividia Health, Inc. · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code descriptio…
- Owner's Booklets and Instructions for Use that are used with the following blood glucose measuring devices. Description/Item: Walgreens TRU…
Trividia Health, Inc. · The system labeling (user manual and online labeling) did not provide adequate directions for lay users to act on the E-5 error code. The error code descriptio…
- CLARITY II Laser System; Model No. 1110200210.
Lutronic Corporation · Reports of devices sparking/popping and potentially burning patients.
- Wondfo Streptococcal A At-Home Self-Test. At-home test for group A beta-hemolytic streptococcal infection.
Altruan GmbH · Product not cleared by the FDA.
- Clearest Strep-A Cassette Test. Test to determine the presence of group A streptococci (Strep A) in throat swab samples.
Altruan GmbH · Product not cleared by the FDA.
- Brand Name: Bisaf Strep A Self-Test. Test for detection of group A streptococcal antigens in throat swabs.
Altruan GmbH · Product not cleared by the FDA.
- Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Mo…
Medline Industries, LP · The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patie…
- Medline Medcrest Surgical Gowns: MDTGXC4J5XL DBQ-GOWN,SURG,XALT,L4, CRTCL CVR, GRN, 5 MDTGXC4JL DBD-GOWN,SURG,XALT,L4,CRTCL CVR,GREEN,L MDT…
Medline Industries, LP · Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may resul…
- Medline Surgical Drapes: MDTBTCS6070GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTBTCS6090GN DBD-DRAPE,COVER,TABLE,RESIS/XALT GRN,60X MDTD…
Medline Industries, LP · Fabric may experience premature delamination when using included laundering instructions. Identifying delaminated gown or drape in a surgical setting may resul…
Device clearances and approvals
FDA date:FDA decided 10 510(k)s and 10 PMA decisions on Thu, Mar 5.
- CORIS System
Nanosonics Limited · General Hospital
- EarliPoint Assessment
Earlitec Diagnostics · Neurology
- Magnifico Open (100009900)
Esaote, S.p.A. · Radiology
- Phantom® Hindfoot TTC/TC Nail System
Paragon 28, Inc. · Orthopedic
- Adhese 2
Ivoclar Vivadent, Inc. · Dental
- Extension tube
Zhuhai DR Medical Instruments Co., Ltd. · Cardiovascular
- AV Cardiac CT
Philips Medical Systems Nederland B.V. · Radiology
- Arthrex FibuLock Nail System
Arthrex, Inc. · Orthopedic
- YUWELL® Electronic Blood Pressure Monitor (YE630CR)
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. · Cardiovascular
- CEPHX3D
Orca Dental AI , Ltd. · Radiology
Label updates
FDA date:161 drug labels took effect on Thu, Mar 5; 5 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Palio Sunscreen Broad Spectrum SPF 30
AVOBENZONE, HOMOSALATE, OCTISALATE · Sole Palio LLC · TOPICAL
- SPF 70 Kids Sunscreen
AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE · Derma Care Research Labs, LLC · TOPICAL
- Sunscreen SPF 50
SUNSCREEN SPF 50 · Guangzhou Ariel Biotech Co., Ltd. · TOPICAL
- Aripiprazole
ARIPIPRAZOLE · Preferred Pharmaceuticals Inc. · ORAL
- montelukast sodium
MONTELUKAST SODIUM · A-S Medication Solutions · 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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