# Major Recall Alert: Temporary Importation of Lentocilin S 1200 Authorized to Mitigate Bicillin L-A Shortage in Canada
Due to a **critical shortage** of the antibiotic Bicillin L-A (1 200 000 IU/2 mL) in Canada, Health Canada has recently approved the **temporary importation and sale** of the Portuguese-authorized **Lentocilin S 1200** (1 200 000 IU/4 mL) by Septa Pharmaceuticals Inc. This measure ensures the continuity of care for patients reliant on this medically necessary antibiotic. However, there are key differences between the two products that healthcare professionals must carefully consider to ensure patient safety.
## Why This Recall is Important
Bicillin L-A is an essential drug used in the intramuscular treatment of infections caused by penicillin-G-sensitive microorganisms. It’s critical in managing conditions like syphilis, rheumatic fever, and other infections requiring prolonged, low-dose penicillin serum levels. With its current shortage, the authorization to use Lentocilin S 1200 bridges the gap, ensuring patients in Canada continue receiving critical care. However, **Lentocilin S has differences in formulation, dosage form, and reconstitution requirements**, which healthcare professionals must note.
## Details of the Recall
- **Imported Product**: Lentocilin S 1200 (1 200 000 IU/4 mL) by Laboratórios Atral, S.A. (Portugal)
- **Reason for Importation**: Bicillin L-A shortage and medical necessity
- **Distributor**: Septa Pharmaceuticals Inc.
- **Key Similarity**: Both Lentocilin S and Bicillin L-A share the same active ingredient (**benzathine benzylpenicillin**) at an identical strength (**1 200 000 IU**) and route of administration (**intramuscular injection**).
- **Key Differences**:
- Lentocilin S is a **powder** requiring reconstitution with a co-packaged **lidocaine hydrochloride 1.5% diluent**, unlike Bicillin L-A, which comes as a **ready-to-use suspension**.
- The reconstituted **injection volume for Lentocilin S** is **4 mL**, double the 2 mL volume of Bicillin L-A.
- Lentocilin S contains non-medicinal ingredients like **soy phospholipids**, which could cause hypersensitivity reactions in soy-allergic patients.
Healthcare professionals must also be cautious of labeling differences since Lentocilin S lacks a drug identification number (DIN) or a scannable barcode usable in Canadian pharmacies.
### Key Warnings
- **Allergic Reactions**: Lentocilin S’s lidocaine-containing diluent and soy phospholipids increase the risk of hypersensitivity (e.g., anaphylactic shock). Evaluate patient medical histories carefully.
- **Adverse Reactions**: Monitor for severe cutaneous adverse reactions (SCAR), which are associated with penicillin G benzathine.
- **Reconstitution Process**: Lentocilin S must be reconstituted immediately before injection. **Use a minimum 18-gauge needle for administration**.
Detailed information on dosing, preparation, storage, and warnings is available in the Lentocilin S Summary of Product Characteristics (SmPC). Refer to the Canadian Product Monograph for Bicillin L-A for additional guidance.
## What You Should Do
### For Healthcare Professionals:
- **Enhanced Monitoring**: Closely monitor patients for potential adverse effects, including hypersensitivity reactions and SCAR.
- **Verify Accuracy**: Double-check product labels to prevent confusion or medication errors.
- **Report Side Effects**: Any serious or unexpected side effects should be reported immediately to Septa Pharmaceuticals or Health Canada (contact details below).
### For Patients:
- **Consult Your Provider**: If you are prescribed Lentocilin S, ensure your healthcare provider discusses the product's differences to avoid adverse reactions.
- **Watch for Symptoms**: Report allergic reactions like rash, hives, or difficulty breathing to your physician immediately.
### Contact Information:
- **To Report Issues**:
- Health Canada: Call 1-866-234-2345 or visit [MedEffect Canada](https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada.html).
- Septa Pharmaceuticals Inc.: Call +1 905-564-5665.
For more details, read the full announcement on the official Health Canada website: [Importation of Portuguese-Authorized Lentocilin S 1200](https://recalls-rappels.canada.ca/en/alert-recall/importation-portuguese-authorized-lentocilin-s-1200-1-200-000-iu-4-ml-due-current).
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By proactively monitoring recalls like the Lentocilin S import, healthcare providers and consumers can continue prioritizing safety while ensuring ongoing access to lifesaving treatments.