Cipla USA, Inc. recalls lanreotide acetate 120 mg/0.5 mL pre-filled syringes distributed nationwide due to lack of assurance of sterility after FDA observations at the contract manufacturer. Health care providers and patients should stop use immediately and contact Cipla or their clinician for guidance.
Lack of Assurance of Sterility: Due to an FDA observation at the contract manufacturing site for deficiencies in their visual inspection procedure.
Consumers and healthcare providers should stop using this product immediately. Contact Cipla USA, Inc. or your healthcare provider for guidance. Notification method: Letter
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Lanreotide acetate is used to treat acromegaly and neuroendocrine tumors. It is administered via subcutaneous injection.
Sterility issues can lead to bacterial contamination or infection at the injection site or systemically.
This recall is not part of a broader industry pattern.
Immediate stop-use instructions; potential infection risk requires medical consultation.
FDA enforcement report D-0423-2026 and Cipla recall communications.
Recall processing timelines vary; expect formal notification by letter.
Keep recall letter, packaging, lot numbers, and any medical records related to administration.
Lanreotide Injection, 120 mg/0.5 mL. Box contains 1 pre-filled syringe. Single-dose only. Rx only. Manufactured by Pharmathen International S.A., Rodopi, Greece. Manufactured for Cipla USA, Inc., 10 Independence Boulevard, Suite 300, Warren, NJ 07059. NDC 69097-906-67. Expiry dates and lot numbers vary by unit.
No incidents or injuries are described in the provided document. The recall status is ACTIVE with HIGH hazard level.
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Cipla USA Inc. recalls 54,583 Lanreotide acetate injections nationwide after FDA flagged sterility assurance concerns at a contract manufacturer. The recall covers a box containing one pre-filled syringe and one safety needle. Healthcare providers and patients should stop using the product immediately and follow the company’s guidance for disposal and refunds.
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