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.
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 a prescription somatostatin analog used to treat certain neuroendocrine tumors. The product is distributed in single-dose pre-filled syringes with a safety needle for healthcare administration.
The sterility concern arises from visual inspection deficiencies at a contract manufacturing site. Contaminated injections could pose infection or other sterility-related risks to patients.
This recall is not described as part of a broader industry pattern in the provided data.
No injuries reported yet. The recall could disrupt treatment for patients who rely on Lanreotide injections. Consumers should seek medical guidance and use alternatives if available.
Recall notification letters from Cipla USA and FDA enforce reports linked above.
Refunds or replacements typically processed within weeks after compliance confirmation; CIPLA recall updates will specify timing.
Keep all recall notices, packaging, NDC labels, lot numbers, and correspondence with Cipla USA for records.
Brand: Lanreotide Acetate. Manufacturer: Pharmathen International S.A., Rodopi, Greece. For: Cipla USA, Inc., Warren, NJ. NDC: 69097-870-67. Distribution: Nationwide in the USA. Quantity: 54,583 syringes. Form: 120 mg*/0.5 mL pre-filled syringe with safety needle. Lot/Expiry: Several lots with Exp 8/31/2027 and Exp 9/30/2027 among listed codes.
No injuries or incidents have been reported in the provided data.
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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.
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