Teva Pharmaceuticals recalled 21,930 cartons of Octreotide Acetate for Injectable Suspension distributed nationwide in the United States. The recall stems from lack of assurance of sterility identified during an FDA inspection at the contract manufacturer. Healthcare providers and patients should stop using this product immediately and contact Teva or a physician for guidance.
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Consumers and healthcare providers should stop using this product immediately. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. Notification method: Letter
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Model numbers/lot information: Lot 4400401; Exp. 6/30/2026. Lot 4401393; Lot 4401494; Lot 4401604; Exp. 9/31/2026. Lot 4500564; Lot 4500601; Lot 4500707; Lot 4500796; Lot 4500859; Lot 4500918; Lot 4500919; Lot 4501006; Exp. 3/31/2027. NDC: 0480-9262-08. Sold nationwide in the USA. Manufacturer: Pharmathen International S.A. (Greece). Manufactured for Teva Pharmaceuticals, Parsippany, NJ. Quantity: 21,930 cartons. Product: Octreotide Acetate for Injectable Suspension, 30 mg, 8 mL single-dose vial. Rx only.
Lack of Assurance of Sterility. Quality system deficiencies identified during an FDA inspection at the contract manufacturer raise concerns about sterility in the injectable suspension.
No injuries or incidents have been reported.
1. Stop using the product. 2. Contact Teva Pharmaceuticals USA, Inc or your healthcare provider for guidance. 3. Do not discard the product until advised. 4. Watch for recall communications by letter from Teva.
Remedy communications by Teva will be issued by letter. Manufacturer: Teva Pharmaceuticals USA, Inc. URL: FDA recall notice linked in the source.
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