Teva Pharmaceuticals Usa, Inc: Octreotide Acetate For Injectable Suspension, For Gluteal Intramuscular Use, 10 Mg, Single-dose
Teva Pharmaceuticals is recalling Octreotide Acetate for Injectable Suspension (10 mg vials) distributed nationwide because manufacturing quality problems mean the company cannot guarantee the product is sterile. The recall was triggered by deficiencies found during an FDA inspection of the Greek manufacturer. This is a Class II recall affecting all states.
- Recalling firm
- Teva Pharmaceuticals USA, Inc
- Product
- Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 10 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece, Manufactured For: TEVA Pharmaceuticals, Parsippany, NJ 07054, NDC 0480-9257-08.
- Reason
- Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
- Classification
- Class II
- Category
- drug recall
- Country
- United States
- Agency
- U.S. Food and Drug Administration
- Recall date
- 2026-03-17
- Status
- Ongoing
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- Nationwide in the USA
Official recall notice from U.S. Food and Drug Administration
Recall details on Nibble Recalls: https://trynibble.app/recalls/d92bfa8f-b064-4fa3-9de8-72487f0ec80a