International reference: 3 US FDA recalls for this ingredient

Adulterated Presence of Foreign Tablets: This product is being recalled becaiuse 30 valacyclovir hydrochloride tablets USP 500 mg were discovered in a bottle labeled Zolpidem Tartrate tables USP 10 mg (valacyclovir)

Presence of Foreign Tablets/Capsules: Potential of Pravastatin tablet fragments in bottles of Valacyclovir 1 gm Tablets. (valacyclovir)

Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penici (valacyclovir)

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

Registered Botswana · BoMRA

APO-VALACYCLOVIR

BOT1702936 CAPLETS

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Registration & product details

Registration no.
BOT1702936
Registration date
2017-04-27
Expiry date
-
Status
Registered/Compliant
Active ingredient
-
Dosage form
CAPLETS
Strength
-
Pack size
-
Therapeutic class
-
Manufacturer / MAH
Apotex
Applicant / LTR
APOTEX INC Apotex Inc. 150 Signet drive, Toronto, Ontario M9L 1T9 Canada
Country of origin
Canada
Manufacturer location
50 Steinway Blvd, Etobicoke, ON M9W 6Y3, Canada

Source: Botswana Medicines Regulatory Authority · fetched 2026-04-15 20:42:39 · updated 2026-10-20 04:31:40

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