RECORDS ARE PUBLISHED REGULATORY ACTIONS. FIELDS THE ISSUING AUTHORITY DID NOT PUBLISH ARE MARKED AS NOT STATED, NEVER FILLED IN.
Drug Eye AfricaNational Actions, Continental Reach
Register / Zambia / DEA-ZM-2026-63941389
Zambia Medicines Regulatory Authority · Zambia
DEA-ZM-2026-63941389
Tier 1 · Regulator-publishedClass IIRecallStatus · active
Issuing authority
Zambia Medicines Regulatory Authority (ZAMRA)
Authority reference
Not stated by the issuing authority
Date issued
07 Jan 2026Format ambiguous in the source; resolved to 2026-01-07 by the table's chronological order.
Recorded by us
2026-09-06 18:40:27 UTC
Product
Cloxispa-250 Cloxacillin Capsules BP 250mg
INN / active substance
Not stated by the issuing authority
Dosage form
Not stated by the issuing authority
Strength
Not stated by the issuing authority
Manufacturer country
Not stated by the issuing authority
MAH or importer
Not stated by the issuing authority
Batch numbers
CC315
Expiry dates
Not published with the notice
Action type
Recall
Classification
Class II as issued
Indicative severity
Not assessed by Drug Eye Africa
Defect category
Out of specification — assay
Product type
Medicine
ATC code
Not stated by the issuing authority
Affected markets
Zambia — no market beyond the issuing country was named on the notice
Cross-border event
Not linked to a cross-border event
Notice text
OOS-Assay
Original language: en
Status
Active
Superseded by
Not superseded. This is the current version.
Version
39

Provenance

Verification tier 1

Where this record came from, and what is held to show it.

Copy of the source
Taken and held by Drug Eye Africa, so the record survives the link above being moved or withdrawn. Not yet published at an address you can open.
Ask us for it and check it against the fingerprint below.
Fingerprint
c54b9a0d9cd089bd9eaa4379b4693a27da3c1e125cac125a556fba6a47e049b3
SHA-256 of the copy held. Any file that produces this number is that copy, byte for byte; any file that does not is a different document.
Copy taken
2026-10-03 10:37:01 UTC

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Same stated defect
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Ipca Laboratories Limited, India
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DEA-ZM-0000-42714800undatedZMKLOXY 250 CLOXACILLIN 250MG CAPSULES
LABORATORY AND ALLIED LIMITED KENYA
86435RecallClass ITier 1 · Regulator-published
Cite this record
Drug Eye Africa (2026). DEA-ZM-2026-63941389: Cloxispa-250 Cloxacillin Capsules BP 250mg — Recall, Zambia Medicines Regulatory Authority. Register of African Regulatory Actions. https://drugeyeafrica.org/register/notice/zm/2026/dea-zm-2026-63941389

Version history

—No version history recorded for this record.
—Corrections appear here and in the site-wide log. Records are superseded, never deleted.

Verification

Tier 1 — Published by the issuing regulator on its own channel and captured by Drug Eye Africa, with the source document archived.

Indexing

This record is indexable: it is dated, names a product, and carries either a batch number or a stated reason.

DEA-ZM-2026-63941389 — Cloxispa-250 Cloxacillin Capsules BP 250mg · Drug Eye Africa