International reference: 1 US FDA recall for this ingredient

Labeling: Label Mixup: MEXILETINE HCL, Capsule, 150 mg may have potentially been mislabeled as the following drug: CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD62865_4, EXP: 5/23/2014. (mexiletine)

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

Registered South Africa · SAHPRA

ARHYTHMEX IV

None

49/6.2/0110

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Sourcing - Kenya only

Registration & product details

Registration no.
49/6.2/0110
Registration date
2022/02/22
Expiry date
-
Status
Registered
Active ingredient
None
Dosage form
-
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
-
Applicant / LTR
ACINO PHARMA (PTY) LTD
Country of origin
-

Source: South African Health Products Regulatory Authority · fetched 2026-04-15 21:19:00 · updated 2026-10-28 04:11:45

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