Monthly reportRWANDAFDA

Rwanda Food and Drugs Authority — May 2021

What this register recorded from RWANDAFDA in May 2021, what other African authorities published in the same month that bears on it, and what we could not read in RWANDAFDA’s own notices. Every figure here is a count of published regulatory actions. None of it is a finding about Rwanda Food and Drugs Authority.

What RWANDAFDA published

8 action(s) recorded: 8 recall.

Reference	Date	Country	Product	Batches	Action	Class	Source
DEA-RW-2021-28347594	25 May 2021	RW	Atropine injection, Pharmax India Pvt.Ltd/India	16222001	Recall	Class I	Tier 1 · Regulator-published
DEA-RW-2021-34272329	25 May 2021	RW	Hyoscine Butylbromide Injection BP 20mg/ml, Centurion Healthcare Private Limited/601, Atlantis Heights, Sarabhai Compound, Vadi Wadi,Vadodara-390 007, Gujarat,INDIA	3H20001	Recall	Class I	Tier 1 · Regulator-published
DEA-RW-2021-35971053	25 May 2021	RW	Phytomenadione Inj. BP 10mg/ml SANJAR PHARMA LLP,Himatnagar-VijapurHighway,Dedhrota,Hitmatnagar-383 220, GUJARAT,INDIA	SA20C008E	Recall	Class I	Tier 1 · Regulator-published
DEA-RW-2021-46787431	25 May 2021	RW	Hyoscine Butylbromide Injection BP 20mg/ml, Centurion Healthcare Private Limited	3H20002	Recall	Class II	Tier 1 · Regulator-published
DEA-RW-2021-53901946	25 May 2021	RW	Nystatin oral suspension BP 100 000 IU/ml DAWA Limited/ KENYA	2006004	Recall	Class II	Tier 1 · Regulator-published
DEA-RW-2021-82999662	25 May 2021	RW	Azithromycin dry powder for suspension (ZEROCIN ) Laboratory&Allied Ltd./kenya	75363	Recall	Class II	Tier 1 · Regulator-published
DEA-RW-2021-94298826	25 May 2021	RW	Amoxicillin 250mg capsule MILAN LABORATORIES (INDIA) PVT. LTD	MP18485A	Recall	Class II	Tier 1 · Regulator-published
DEA-RW-2021-98319060	25 May 2021	RW	Furosemide injection 20mg/2ml, Laborate Pharmaceuticals India	JFDIE-001	Recall	Class I	Tier 1 · Regulator-published

What other authorities published

Nothing published elsewhere this month joins to RWANDAFDA by either of the two links this register will draw — a shared event, or a manufacturer RWANDAFDA has itself named. That is a statement about those two links and not about the month.

What we could not read in RWANDAFDA’s notices

Our failures on RWANDAFDA’s coverage, across the whole register rather than this month. Published because a report that told an authority only what it was missing would be an audit sent by someone with no standing to conduct one.

159 record(s) held from RWANDAFDA in total
2 carry no publication date we could read
22 name neither a batch nor a stated reason
1 name no manufacturer
2 are searchable and API-available but carry noindex, because they are too incomplete for a public URL
0 have no archived copy of the original notice

Each of these is something RWANDAFDA published and this register did not capture, or captured incompletely. None of them is a failure by RWANDAFDA.

Correcting this

Anything on this page that is wrong about Rwanda Food and Drugs Authority can be corrected by Rwanda Food and Drugs Authority, and a record published by one of its officers carries verification tier 0 — the rank only the issuing regulator can create. Nothing else on this register does.

Write to notices@drugeyeafrica.org. Corrections to existing records are logged and published on the corrections page; a superseded record keeps its URL and points forward to the one that replaced it.

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