FDA daily for Tuesday, October 20, 2026
In this issue: 32 shortage updates, 5 approvals, 4 device recalls, 16 device decisions and 4 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.
- Sterile Water Irrigant
B. Braun Medical Inc. · Available
- MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc. · Cardiovascular
Drug shortages
FDA date:FDA updated 32 shortage entries on Mon, Oct 19: 1 new, 1 to be discontinued, 30 status updates.
- Sterile Water Irrigant
B. Braun Medical Inc. · Available
- Lamivudine Tablet
ViiV Healthcare Company
- Dextrose Monohydrate 5% Injection
B. Braun Medical Inc. · Available
- Lidocaine Hydrochloride Injection
Eugia US LLC · Available
- Ropivacaine Hydrochloride Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
- Dexmedetomidine Hydrochloride Injection
Eugia US LLC · Available
- Dexamethasone Sodium Phosphate Injection
Eugia US LLC · Available
- Dexmedetomidine Hydrochloride Injection
Mylan Institutional, a Viatris Company · Available
- Azacitidine Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
- Methylphenidate Hydrochloride Tablet, Extended Release
Sun Pharmaceutical Industries, Inc. · Unavailable · Reason: Discontinuation of the manufacture of the drug
- Technetium TC-99M Pyrophosphate Kit Injection
Sun Pharmaceutical Industries, Inc. · Unavailable · Reason: Other
- Lisdexamfetamine Dimesylate Tablet, Chewable
Sun Pharmaceutical Industries, Inc. · Available
- Amino Acid Injection
B. Braun Medical Inc. · Available
- Lisdexamfetamine Dimesylate Capsule
Sun Pharmaceutical Industries, Inc. · Limited Availability · Reason: Other
- Methylprednisolone Acetate Injection
Eugia US LLC · Unavailable · Reason: Demand increase for the drug
Drug and biologic approvals
FDA date:On Tue, Oct 13 FDA approved 1 new application (0 brand or biologic, 1 generic) and 4 supplements to existing ones.
- MEMANTINE HYDROCHLORIDE AND DONEPEZIL HYDROCHLORIDE
STRIDES PHARMA INTL · DONEPEZIL HYDROCHLORIDE, MEMANTINE HYDROCHLORIDE
Device recalls
FDA date:FDA posted 4 device recalls from 2 firms on Tue, Oct 13.
- Generic Name: FilmArray Pneumonia Panel Generic Name: FilmArray Pneumonia Panel Model/Catalog Number: RFIT-ASY-0144 (30 pack), RFIT-ASY-014…
BioFire Diagnostics, LLC · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Generic Name: FilmArray Pneumonia Panel plus Generic Name: FilmArray Pneumonia Panel plus Model/Catalog Number: RFIT-ASY-0143 (30 Kit), RFI…
BioFire Diagnostics, LLC · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Generic Name: BioFire Joint Infection (JI) Panel Generic Name: BioFire Joint Infection (JI) Panel Model/Catalog Number: RFIT-ASY-0138 (30 K…
BioFire Diagnostics, LLC · Due to potential contaiminated of spefic lots of pneumonia and joint infection panels that could result in false positive results
- Likorall Overhead Lifts Product Code: 3121001 Product Description: LIKORALL 200 Product Code: 3122005 Product Description: LIKORALL 242 ES,…
Baxter Healthcare Corporation · Potential issue involving motor shaft breakage combined with reduced performance of the Single Fault Safety (SFS) system may lead to instances where the lift s…
Device clearances and approvals
FDA date:FDA decided 9 510(k)s and 7 PMA decisions on Tue, Oct 6.
- MEDRAD® MRXperion MR Injection System and MR Injection System Syringe Kit; MEDRAD® IS12 Module (IS12); MEDRAD® Imaging Bulk Package Transfer Spike
Bayer Medical Care, Inc. · Cardiovascular
- LOBO Vascular Occlusion System
Okami Medical, Inc. · Cardiovascular
- OpenFlo Urinary Catheter
Urolution Medical, Inc. · Gastroenterology, Urology
- Power Wheelchair (DC12)
Anhui JBH Medical Apparatus Co., Ltd. · Physical Medicine
- APRO 88 Catheter
Alembic, LLC · Cardiovascular
- Power Wheelchair (D60)
Anhui JBH Medical Apparatus Co., Ltd. · Physical Medicine
- TSK OptiXion
Tsk Laboratory, Japan · General Hospital
- Forza
True Function Laboratory, Inc. · Dental
Label updates
FDA date:4 drug labels took effect on Tue, Oct 6. Below: those, and labels carrying a boxed warning.
- Amlodipine and Benazepril Hydrochloride
AMLODIPINE AND BENAZEPRIL HYDROCHLORIDE · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals 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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