Monthly reportSAHPRA

South African Health Products Regulatory Authority — September 2022

What this register recorded from SAHPRA in September 2022, what other African authorities published in the same month that bears on it, and what we could not read in SAHPRA’s own notices. Every figure here is a count of published regulatory actions. None of it is a finding about South African Health Products Regulatory Authority.

What SAHPRA published

4 action(s) recorded: 4 recall.

Reference	Date	Country	Product	Batches	Action	Class	Source
DEA-ZA-2022-46630416	05 Sept 2022	ZA	JANUMET 50/850mg and JANUMET 50/1000mg (50mg of Sitagliptin with 850mg of Metformin Hydrochloride AND 50mg of Sitagliptin with 1000mg of Metformin Hydrochloride)	W01552 · W01553	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-15858179	09 Sept 2022	ZA	Vitaforce Schlehen Blackthorn Berry Elixir (Ascorbic acid (Vit C) 33,5 mg) Ascendis Consumer Brands (Pty) Ltd	151717 · 151848 · 151725 · 151844 · 152003	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-0000-99566099	12 Sept 2022	ZA	Lancap 15mg capsules (Lansoprazole) Pharma Dynamics (Pty) Ltd	SJ2758 · SJ3425 · SJ2652 · SJ8693	Recall	Class III	Tier 1 · Regulator-published
DEA-ZA-2022-51900791	29 Sept 2022	ZA	Austell Azithromycin (Azithromycin 200 mg/5 ml powder for suspension) Austell Pharmaceuticals	MG22413 · MG22414 · MG22415	Recall	Class III	Tier 1 · Regulator-published

What other authorities published

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

What we could not read in SAHPRA’s notices

Our failures on SAHPRA’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.

121 record(s) held from SAHPRA in total
3 carry no publication date we could read
30 name neither a batch nor a stated reason
48 name no manufacturer
30 are searchable and API-available but carry noindex, because they are too incomplete for a public URL
23 have no archived copy of the original notice

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

Correcting this

Anything on this page that is wrong about South African Health Products Regulatory Authority can be corrected by South African Health Products Regulatory 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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