FDA daily for Tuesday, November 10, 2026
In this issue: 26 shortage updates, 18 approvals, 26 device recalls, 31 device decisions and 226 label changes. 3 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.
- Sterile Water Injection
Hospira, Inc., a Pfizer Company · Available
- Note Mattifying Extreme Wear Foundation
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Tretinoin
TRETINOIN · A-S Medication Solutions · TOPICAL
Drug shortages
FDA date:FDA updated 26 shortage entries on Mon, Nov 9: 26 status updates.
- Sterile Water Injection
Hospira, Inc., a Pfizer Company · Available
- Heparin Sodium Injection
Hospira, Inc., a Pfizer Company · Available
- Dopamine Hydrochloride Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Bupivacaine Hydrochloride Injection
Hospira, Inc., a Pfizer Company · Available
- Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Carboplatin Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Lidocaine Hydrochloride Injection
Hospira, Inc., a Pfizer Company · Available
- Bupivacaine Hydrochloride, Epinephrine Bitartrate Injection
Hospira, Inc., a Pfizer Company · Limited Availability · Reason: Other
- Furosemide Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Fentanyl Citrate Injection
Hospira, Inc., a Pfizer Company · Available
- Hydromorphone Hydrochloride Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Ketorolac Tromethamine Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
- Sodium Acetate Injection
Hospira, Inc., a Pfizer Company · Available
- Rocuronium Bromide Injection
Sandoz Inc. · Available
- Methotrexate Sodium Injection
Hospira, Inc., a Pfizer Company · Unavailable · Reason: Other
Drug and biologic approvals
FDA date:On Tue, Nov 3 FDA approved 4 new applications (0 brand or biologic, 4 generic) and 14 supplements to existing ones.
- OLOPATADINE HYDROCHLORIDE
ALEMBIC · OLOPATADINE HYDROCHLORIDE
- FLUTICASONE PROPIONATE
TEVA PHARMS USA INC · FLUTICASONE PROPIONATE
- HYDROXYUREA
ESJAY PHARMA · HYDROXYUREA
- PROPOFOL
BAXTER HLTHCARE CORP · PROPOFOL
Device recalls
FDA date:FDA posted 26 device recalls from 8 firms on Tue, Nov 3.
- Halyard MINOR PACK. Model/Catalog Number: VASF105-08.
AVID Medical, Inc. · Potential for open seals on header bags, compromising sterility.
- TruSystem 7000 U Operating Table (dV), Product Code 1723633
Baxter Healthcare Corporation · The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occ…
- Mobile column TruSystem 7500 U, Product Code 1730720
Baxter Healthcare Corporation · The main lift may unexpectedly drop from its set position to its lowest position during use. The tabletop may not be able to be raised again after the drop occ…
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Suture; Model/Catalog Number: PSN8696P (Henry Schein Item No. 600-0115); Pro…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN397V (Henry Schein Item No. 600-0…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN7772S (HSI Item No. 600-3090)…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN632S (HSI Item No. 600-3506);…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8698P (HSI Item No.…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411);…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN421V (HSI Item No. 600-6870); Pro…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8660P (HSI Item No.…
Henry Schein Inc. · Products lack 510(k) clearance.
- Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8384P (HSI Item No.…
Henry Schein Inc. · Products lack 510(k) clearance.
Device clearances and approvals
FDA date:FDA decided 14 510(k)s and 17 PMA decisions on Tue, Oct 27, including 1 original PMA.
- Amplatzer Paraclose PVL Occluder
ABBOTT MEDICAL · Para-device leak occluder · Cardiovascular
- Skin Clinic Nitro Clear for Warts and Skin Tags
Cryoconcepts LP · General, Plastic Surgery
- FlowXL® System: FlowXL Flowmeter and compatible Flowprobes and Flowsensors
Transonic Systems, Inc. · Cardiovascular
- Diode laser device (DT25-BI, DT212-BI, DT213-BI, DT214-BI, DT215-BI)
Risu Medical Technology Co., Ltd. · General, Plastic Surgery
- OsteoSight Spine (v1)
Naitive Technologies, Ltd. · Radiology
- OnControl Powered Bone Access Systems;OnControl Bone Marrow Aspiration System;OnControl Bone Marrow Biopsy System;OnControl Bone Lesion Biopsy System;OnControl Power Driver
Teleflex Medical, LLC · Gastroenterology, Urology
- Adaptive Optics Scanning Laser Ophthalmoscope (Mona IV)
Robotrak Technologies Co., Ltd. · Ophthalmic
- AquaVance Clear Fluoride Treatment
The Belport Company Inc., DBA Gingi-Pak · Dental
- Nimbl Pneumatic Compression System
Tactile Medical · Cardiovascular
- Tendon Anchor
Smith & Nephew, Inc. · General, Plastic Surgery
- BD Veritor System for SARS-CoV-2
BD Diagnostic Solutions / Becton, Dickinson & Company · Microbiology
- DORO® Headrest System for AVA
Black Forest Medical GmbH · Neurology
- Arthrex FiberButton
Arthrex, Inc. · Orthopedic
- PulseAPI SmartWatch
PulseAI, Ltd. · Cardiovascular
Label updates
FDA date:226 drug labels took effect on Tue, Oct 27; 2 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Note Mattifying Extreme Wear Foundation
OCTINOXATE · ALTONA COSMETICS TECHNOLOGY SANAYI VE TICARET ANONIM SIRKETI · TOPICAL
- Tretinoin
TRETINOIN · A-S Medication Solutions · TOPICAL
- Carmustine
CARMUSTINE · Navinta LLC
- XELSTRYM
DEXTROAMPHETAMINE · Noven Therapeutics, LLC · TRANSDERMAL
- Clonazepam
CLONAZEPAM · PD-Rx Pharmaceuticals, Inc. · ORAL
- sirolimus
SIROLIMUS · REMEDYREPACK INC. · ORAL
- carmustine
CARMUSTINE · Zydus Pharmaceuticals USA Inc.
- Methotrexate
METHOTREXATE · Hospira, Inc. · INTRAMUSCULAR, INTRAVENOUS +2
- Levothyroxine sodium
LEVOTHYROXINE SODIUM · REMEDYREPACK INC. · ORAL
FDA did not answer for Drug recalls, Food and supplement recalls while this issue was written; those sections will fill in on a later visit.
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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