Medefil, Inc.: FDA regulatory profile

Medefil, Inc. appears in 1 indexed U.S. FDA record: 1 drug-shortage entry (from 1 openFDA source row), naming 1 distinct product. Latest dated event: a shortage record dated 2026-08-17. Observations run 2021-11-23 to 2026-08-17 — 1728 days, 2 dated records across 2 calendar years, busiest 2026 with 1. Shortages: 1 current, averaging 1 package lines each across 1 FDA therapeutic category, 1 strength, 7 package NDCs and 0 brand names. 2 related firms and 5 adjacent shortage entries are linked below, each by a shared shortage entry, substance or therapeutic category. Every figure here is a count or a date computed from the indexed FDA datasets over a finite window: coverage-limited activity signals, never quality ratings or judgements about the firm. By year: 2026 (1), 2021 (1). Shortage entries include Sterile Water Injection (Current, since 2021-11-23, 1 lines). FDA therapeutic categories covered: Other. Strengths reported: 10 mL/10 mL. Related firms include Baxter Healthcare and Otsuka Icu Medical LLC. This firm appears in 1 indexed record, which is below the threshold this site requires before treating a manufacturer page as a standalone regulatory profile (only 1 indexed record). The page is published so the record remains reachable and verifiable, and it links on to the underlying FDA records, but it is marked noindex and left out of the sitemap: a single appearance of a company name is not a regulatory history, and presenting it as one would overstate what the data supports. Should further records reference this firm in a later ingestion, the page becomes a full profile automatically.

Regulatory snapshot

Indexed records 1
Recall records 0
Shortage entries 1
Source rows filed 1
Approval records 0
Current shortages 1
Resolved shortages 0
Discontinued shortages 0
Unique products 1
Recall classifications 0
Recall statuses 0
First observed 2021-11-23
Latest observed 2026-08-17
Latest event type shortage
Dated observations 2
Years covered 2
Span (days) 1728
Busiest year 2026 (1 records)
Lines per entry (mean) 1
Therapeutic categories 1
Distinct strengths 1
Package NDCs 7
Brand names 0
Related firms / shortages 2 / 5

Counts, not a rating. Coverage-limited activity signals over the ingested window — never reputational scores or judgements about the firm or its products.

Record breakdown

DimensionValueRecordsShare
Shortage statusCurrent1100%
Therapeutic categoryOther1100%

Current shortages (1)

Reported by this firm and recorded by the FDA as active. Each links to its canonical entry.

ShortageStatusSinceUpdatedLines filedPresentationsStrengths
Sterile Water Injection Current 2021-11-23 2026-08-17 1 1 10 mL/10 mL

Package lines filed (1)

The openFDA shortage lines this firm filed, with the agency's own availability text.

ShortagePresentationStrengthPackage NDCStatusAvailability (FDA text)Updated
Sterile Water Injection Sterile Water, Injection, 10 mL/10 mL (NDC 64253-020-30) 10 mL/10 mL 64253-020-30 Current Available 2026-08-17

Products and drugs named (1)

De-duplicated by record entity, not raw source row.

Product / drugRecord typeLinesDate
Sterile Water Injection shortage 1 2026-08-17

Related manufacturers

Linked by a co-reported shortage entry or a shortage of the same active substance — never inferred from name or sector.

FirmRelationRecordsRecallsShortagesLatest
Baxter Healthcare reports a shortage of the same substance 14 0 14 2026-08-20
Otsuka Icu Medical LLC reports a shortage of the same substance 5 0 5 2026-08-17

Related shortages in this firm's areas

Not reported by this firm, but sharing a substance identifier or therapeutic category with one that is.

ShortageStatusRelationSinceUpdatedPresentationsFirms
Dexamethasone Sodium Phosphate Injection Current same therapeutic category 2019-02-08 2026-08-20 4 1
Dextrose Monohydrate 10% Injection Current same therapeutic category 2022-03-01 2026-08-17 4 2
Dextrose Monohydrate 5% Injection Current same therapeutic category 2022-02-14 2026-08-17 14 2
Dextrose Monohydrate 70% Injection Current same therapeutic category 2024-10-11 2026-08-17 1 1
Sterile Water Irrigant Current same substance 2023-04-28 2026-08-17 2 2

Source limitations

Built from the 1 ingested FDA record for this firm (0 recall, 1 shortage, 0 approval) — not its full regulatory history. The window is finite and can lag the live record, and alternate spellings of a firm name may sit under separate profiles. Confirm details at the linked official source. Regulatory information only: no safety assessment, no recommendation.

Where to go next

Source & provenance

Official source
https://open.fda.gov/apis/drug/enforcement/
Source dataset
openFDA (enforcement + shortages + Drugs@FDA)
Publication date
Not available
Ingested
2026-08-22

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.