Octreotide Acetate for Injectable Suspension recall: Sterility Concern
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY…
Why was Octreotide Acetate for Injectable Suspension recalled?
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot: 4401619, Exp.: 09/30/2026; 4501005, 03/31/2027.
- Product
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial in Kit, Rx only, Manufactured in Greece BY…
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Quantity
- 1,897 Cartons
- Distribution
- Nationwide in the USA
- Recall date
- April 1, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)