International reference: 1 US FDA recall for this ingredient

CGMP Deviations: Intermittent exposure to temperature excursion during storage. (azilsartan)

US-market enforcement records (OpenFDA), shown for reference - not specific to this product in South Africa.

Registered South Africa · SAHPRA

ANTALUKO 5

None

45/10.2.2/0456

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Answers come only from this medicine's registration record, BNF monograph and interaction data - not medical advice.

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Sourcing - Kenya only

Registration & product details

Registration no.
45/10.2.2/0456
Registration date
2022/07/19
Expiry date
-
Status
Registered
Active ingredient
None
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
LHC Pharmaceuticals (Pty) Ltd
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:27:15 · updated 2026-10-18 04:02:14

Disclaimer: This information is sourced from South African Health Products Regulatory Authority (South Africa). Always consult a qualified healthcare professional before using any medication.