National Drug Authority · Uganda
DEA-UG-2019-52040565
Tier 1 · Regulator-publishedUnclassifiedRecallStatus · active
- Issuing authority
- National Drug Authority (NDA)
- Authority reference
- 047/NDA/DPS/01/2019
- Date issued
- 22 Jan 2019Read from the archived document: printed date '22M January 2019'. The circulars page states no date, and the month shown as uploaded is when the file reached the Authority's website.
- Recorded by us
- 2026-09-09 22:24:19 UTC
- Product
- Furosemide Injection BP
- INN / active substance
- Furosemide
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Grand Pharmaceutical (China) Co., Ltd.
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- 180120
- Expiry dates
- 01/2021
- Action type
- Recall
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Labelling error
- Product type
- Medicine
- ATC code
- Not stated by the issuing authority
- Affected markets
- Uganda — no market beyond the issuing country was named on the notice
- Cross-border event
- Not linked to a cross-border event
- Notice text
- National Drug Authority in its routine Post Marketing Surveillance discovered that the product with details below has mismatching information on the Patient Information Leaflet (PIL) and both the primary and secondary packages. The product strength indicated on both the primary and secondary packages is 10mg/2ml whereas the PIL shows product to be of strength 10mg/ml. The above mismatching information is confusing, misleading and can lead to wrong/irrational use of the drug.Original language: en
- Status
- Active
- Superseded by
- Not superseded. This is the current version.
- Version
- 7
Where this record came from, and what is held to show it.
- Primary source
- https://www.nda.or.ug/wp-content/uploads/2022/02/REF.NO_.047-CIRCULAR-NO.028-FUROSEMIDE-INJECTION.pdf
- Copy of the source
- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.Ask us for it and check it against the fingerprint below.
- Fingerprint
- da812a4b2df724b8ccc6ae7f159d37c08082a5cae737ba0906631eff8320a74eSHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
- Copy taken
- 2026-09-09 22:26:41 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-KE-2025-0033 | 28 Oct 2025 | KE | Magnesium Sulfate Laboratory & Allied Ltd, Kenya | 85055 · 86718 · 88683 · 88688 · 88690 · 89181 · 89182 · 89183 | Recall | Unclassified | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2019). DEA-UG-2019-52040565: Furosemide Injection BP — Recall, National Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ug/2019/dea-ug-2019-52040565Version history
—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.
Verification
Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.
Indexing
This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.