International reference: 4 US FDA recalls for this ingredient

Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample. (leucovorin)

Lack of Assurance of Sterility (leucovorin)

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

Lack of Assurance of Sterility (leucovorin)

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

Registered Botswana · BoMRA

ABIC LEUCOVORIN INJECTION

BOT1803298 SOLUTION FOR INJECTION

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Sourcing - Kenya only

Registration & product details

Registration no.
BOT1803298
Registration date
2018-03-20
Expiry date
-
Status
Registered/Compliant
Active ingredient
-
Dosage form
SOLUTION FOR INJECTION
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Pharmachemie
Applicant / LTR
TEVA PHARMACEUTICALS (PTY) LTD Building 3, Maxwell Office Park, Magwa Crescent West, Waterfall City, Midrand, Gauteng, 2090
Country of origin
Netherlands
Manufacturer location
Swensweg 5, 2031 GA Haarlem, Netherlands

Source: Botswana Medicines Regulatory Authority · fetched 2026-04-15 20:42:11 · updated 2026-10-20 04:31:19

Disclaimer: This information is sourced from Botswana Medicines Regulatory Authority (Botswana). Always consult a qualified healthcare professional before using any medication.