Cipla USA, Inc. is recalling 15,221 Lanreotide Acetate Injection syringes nationwide in the United States after detecting particulate matter. The defect is the presence of particulate matter in the injectable solution. Healthcare providers and patients should stop using the product immediately and contact Cipla USA for guidance.
Presence of Particulate Matter.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance
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Lanreotide Acetate Injection, 120 mg/0.5 mL. 0.5 mL per pre-filled syringe. For deep subcutaneous injection. NDC 69097-870-67. Sold nationwide in the USA. Manufactured for Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Quantity: 15,221 syringes. Recall Date: 2026-01-02. Status: ACTIVE. Distribution: Nationwide in the USA.
Presence of particulate matter in Lanreotide Acetate Injection solution. Consumers may receive particulates during injection, which could cause adverse effects.
1. Stop using the product. 2. Contact your healthcare provider for guidance. 3. Refer to the recall notice for instructions on next steps and potential replacement options. 4. Do not discard until advised. 5. Report any adverse events to FDA MedWatch.
FDA recall enforcement page: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0290-2026. Cipla USA, Inc. address: 10 Independence Boulevard, Suite 300, Warren, NJ 07059. Phone and hours not listed in the notice.
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