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DRAP23 Oct 2026DRAP Alert I/S/10-26-45, dated 23 October 2026

DRAP orders withdrawal of Carapamin batch 26A059 and Librax batch 001952

Active safety recallSafety recall alert

DRAP Alert 45 directs removal of two identified batches: Carapamin Injection 200mg, batch 26A059, and Librax Tablet, batch 001952. The laboratory table records organic impurities above permitted limits.

REGULATORY INTELLIGENCE / RESEARCH NOTE

Official primary source: DRAP Alert I/S/10-26-45, dated 23 October 2026 · Reviewed 26 October 2026. Legal effect, provisional status and dates are identified below; the full official document and any later amendments govern.

The alert is batch-specific: facilities and pharmacies should stop supplying the identified batches, quarantine remaining stock and arrange its return.

01 / REGULATORY ANALYSIS

Exactly which products and batches are affected

DRAP Recall Alert No. I/S/10-26-45, issued 23 October 2026, identifies Carapamin Injection 200mg (dopamine hydrochloride USP), registration 060235, batch 26A059, manufactured by Caraway Pharmaceuticals in the Rawat industrial area; and Librax Tablet (chlordiazepoxide 5mg / clidinium bromide 2.5mg), registration 000568, batch 001952, manufactured by Martin Dow Limited, Karachi.

The table of batch-specific laboratory findings describes organic impurities exceeding the permitted limits in testing by the Punjab drug-testing laboratories (Lahore for Carapamin and Faisalabad for Librax). The general preamble of the alert refers to sterility testing, so the detailed batch table should be consulted for the recorded defect; the brief does not equate these distinct types of test failure.

The alert concerns the stated batches. It does not establish that every batch manufactured under either brand has failed testing.

02 / REGULATORY ANALYSIS

Immediate recall action required across the supply chain

DRAP has requested market surveillance and removal by its field offices and provincial drug-control authorities. The notification instructs pharmacists and chemists to examine inventory immediately, cease supply of the named batches and quarantine remaining stock for return to the supplier or manufacturer.

Hospitals, clinics, institutional buyers and distributors should identify affected inventory by batch number, segregate it from saleable stock and maintain documentary records of supplier returns, affected stock quantities and any related quality complaints.

DRAP identifies potential health risks from the impurities and calls for heightened vigilance, particularly with vulnerable patients and continuing medication users.

03 / REGULATORY ANALYSIS

Practical compliance and patient-safety steps

Businesses should circulate an internal batch notice to procurement, distribution, pharmacy and clinical teams, trace affected consignments and follow the regulator's return and disposal instructions. The recall is not a substitute for assessment of other product quality obligations.

Patients possessing the identified batches should stop using them and contact a healthcare professional promptly about an appropriate replacement or treatment. Suspected adverse effects or product defects should be reported through DRAP's National Pharmacovigilance Centre.

Maintain batch-level records of quarantine, returns, customer notifications and regulator correspondence, and monitor DRAP for follow-up directions.

CHAMBERS / PRACTICAL VIEW

Why this development matters

Healthcare and distribution businesses should activate batch-specific recall procedures immediately; patients holding affected product should seek clinical advice.

Specific steps for affected organisations

  • Check stock and purchase records for Carapamin batch 26A059 and Librax batch 001952.
  • Immediately stop distribution of identified stock and quarantine it for return.
  • Notify pharmacy, clinical, hospital procurement and distribution teams.
  • Record traceability and returns, and report quality incidents or adverse events to DRAP.

Timing and legal status

DRAP Alert I/S/10-26-45 dated 23 October 2026; the recall instruction calls for immediate action, not a deferred commencement.

The alert describes a batch-specific regulatory action. Its introduction refers to sterility testing while the detailed product table cites excessive organic impurities; users should read DRAP's original batch particulars.

PRIMARY REFERENCEDRAP Alert I/S/10-26-45, dated 23 October 2026

Drug Regulatory Authority of Pakistan — Recall Alert I/S/10-26-45 (23 October 2026)

READ THE ORIGINAL REGULATORY SOURCE ↗