The Instituto de Salud Pública (ISP) announced a voluntary recall for batches of Loratadina Solución Oral 5 mg/5 mL, an oral antihistamine used to treat allergies, following a quality complaint regarding a defect inside the bottle cap. According to an alert issued by the regulatory agency, opening the affected medication bottles can produce a black thread on the interior side of the cap.
Affected Medication Batches and Product Details
The voluntary recall impacts specific production series distributed in 60-milliliter amber glass bottles. According to regulatory documents, the active ingredient is loratadine, and the sanitary registration number is F-25492. The product’s marketing authorization holder is Neoethicals Chile SpA, and it is manufactured by Caplin Point Laboratories Ltd. in India.
Patients and healthcare providers can identify the recalled units by checking the packaging for the following batch numbers and expiration dates:
- Batch L014B24: Expiration between January and February 2027.
- Batch L013B24: Expiration between January and February 2027.
- Batch L011B24: Expiration between January and February 2027.
- Batch L010B24: Expiration between January and February 2027.
- Batch L016C24: Expiration between January and February 2027.
Regulatory Response and Consumer Guidance
The recall was initiated after the regulatory agency received a formal quality complaint concerning the physical defect on the bottle cap interior. While the notice classifies the action as a voluntary withdrawal by the holder, regulatory officials advise consumers to inspect their medicine cabinets immediately.
Patients who possess an oral antihistamine matching the specified sanitary registration and batch numbers should avoid using the product.
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