National Drug Authority · Uganda
DEA-UG-2019-36916109
Tier 1 · Regulator-publishedUnclassifiedImport holdStatus · active
- Issuing authority
- National Drug Authority (NDA)
- Authority reference
- 707/NDA/DPS/10/2019
- Date issued
- 31 Oct 2019Read from the archived document: printed date '31st October 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
- Ranitidine
- INN / active substance
- Ranitidine
- Dosage form
- Not stated by the issuing authority
- Strength
- Not stated by the issuing authority
- Manufacturer
- Not stated by the issuing authority
- Manufacturer country
- Not stated by the issuing authority
- MAH or importer
- Not stated by the issuing authority
- Batch numbers
- Not published with the notice
- Expiry dates
- Not published with the notice
- Action type
- Import hold
- Classification
- Not stated by the issuing authority
- Indicative severity
- Not assessed by Drug Eye Africa
- Defect category
- Impurity
- 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 (NDA) received alerts from the United States Food and Drug Authority that Ranitidine, a histamine H2 receptor antagonist, prescribed for Dyspepsia and Gastroesophageal reflux disease (GERD), contains a substance known as N-nitrosodimethylamine (NDMA). N-nitrosodimethylamine at high levels is a known human carcinogen of genotoxic nature. NDA has halted the importation and distribution of Ranitidine into the country, pending further regulatory action that will follow conclusion of investigations into the levels of contamination with NDMA in registered brands of Ranitidine.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- Superseded by
- Not superseded.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.
- 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- Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn.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
- 75d8e09615fbc4c538630cc660fd4da6f04cd669dafb929076c51d525ace4c4bSHA-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 22:26:38 UTC
| Reference | Date | Ctry | Product | Batches | Action | Class | Source |
|---|---|---|---|---|---|---|---|
| DEA-RW-0000-86468251 | 07 Oct 2021 | RW | Losar-Denk 50 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-51547910 | 07 Oct 2021 | RW | Losar-Denk 25 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-40943378 | 07 Oct 2021 | RW | Colosar-Denk 100 mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-25020792 | 07 Oct 2021 | RW | Losar-Denk 100 mg film Coated DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
| DEA-RW-0000-16076249 | 07 Oct 2021 | RW | Colosar-Denk 50mg /12,5mg film coated tablet DENK PHARMA | none published | Recall | Class I | Tier 1 · Regulator-published |
Cite this record
Drug Eye Africa (2019). DEA-UG-2019-36916109: Ranitidine — Import hold, National Drug Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/ug/2019/dea-ug-2019-36916109Version 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.