FDA daily for Monday, September 21, 2026
In this issue: 18 approvals, 9 device recalls and 32 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.
- ALCOHOL PREP PADS MEDIUM STERILE
ISOPROPYL ALCOHOL CLOTH · JINHUA JINGDI MEDICAL SUPPLIES CO., LTD · TOPICAL
Drug and biologic approvals
FDA date:On Mon, Sep 14 FDA approved 5 new applications (1 brand or biologic, 4 generic) and 13 supplements to existing ones.
- BEXLUTRY
CURIUM · LUTETIUM LU 177 DONATATE
- LETROZOLE
ZYDUS LIFESCIENCES · LETROZOLE
- BECLOMETHASONE DIPROPIONATE
AUROLIFE PHARMA LLC · BECLOMETHASONE DIPROPIONATE
- HALOPERIDOL
AJANTA PHARMA LTD · HALOPERIDOL
- EPINEPHRINE
ZYDUS PHARMS · EPINEPHRINE
Device recalls
FDA date:FDA posted 9 device recalls from 3 firms on Mon, Sep 14.
- Halyard IV START KIT NON-STERILE REF: KRIV26-02
AVID Medical, Inc. · Convenience kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which are contaminated with Aspergillus penicillioides
- Medline Convenience Kits: 1) KIT ANESTHESIA L&D A- LINE SET, Catalog Number: DYKMBNDL199A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) OPEN HEART ADULT, Catalog Number: CDS840396Y; 2) FULL LINE ANEURYSM CDS, Catalog Number: CDS983672O; 3) NON ST…
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) PORT ACCESS KIT UNIV OF ALA, Catalog Number: DYKM1414; 2) ARTERIAL LINE ST JOES SYR PACK, Catalog Number: DYNJ…
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) ACC010308A, Catalog Number: ACC010308A; 2) ACC010374A, Catalog Number: ACC010374A; 3) ACC010679, Catalog Numbe…
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) DYKM1000B, Catalog Number: DYKM1000B; 2) DYKM2187A, Catalog Number: DYKM2187A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) DYNDH1193, Catalog Number: DYNDH1193; 2) DYNDH1487A, Catalog Number: DYNDH1487A
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Medline Convenience Kits: 1) DYNDB3086D, Catalog Number: DYNDB3086D; 2) DYNDB3100, Catalog Number: DYNDB3100; 3) DYNDH1619A, Catalog Number…
Medline Industries, LP · The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the…
- Brand Name: DASH Rapid PCR Instrument Product Name: DASH Rapid PCR Instrument Model/Catalog Number: SG-0002 Software Version: 6.0.2, 6.0.4,…
Nuclein LLC · Due to a software issue
Label updates
FDA date:32 drug labels took effect on Mon, Sep 7; 1 of the 25 read for this issue is for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- ALCOHOL PREP PADS MEDIUM STERILE
ISOPROPYL ALCOHOL CLOTH · JINHUA JINGDI MEDICAL SUPPLIES CO., LTD · TOPICAL
- ISOTRETINOIN
ISOTRETINOIN · Aurobindo Pharma Limited · ORAL
- Mycophenolate mofetil
MYCOPHENOLATE MOFETIL · Strides Pharma Inc. · ORAL
- Candesartan cilexetil
CANDESARTAN CILEXETIL · Viona Pharmaceuticals Inc · ORAL
FDA did not answer for Clearances, Drug recalls, Food and supplement recalls, Drug shortages 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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