HIGH
CUROSURF (poractant alfa), 240 mg, Intratracheal Suspension, 3L Single-dose-Vial, Rx only, Chiesi USA, Inc, Cary, NC 27518, NDC 10122-510-03.
Lack of Assurance of Sterility
CUROSURF
Lack of
HIGH
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 mg, Single-dose 8 mL vial, Rx only, Manufactured in Greece BY: Pharmathen International S.A, Rodopi, 693 00 Greece,...
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.
Quick Facts at a Glance
- Recall Date
- March 17, 2026
- Hazard Level
- HIGH
- Brands
- OCTREOTIDE ACETATE, Teva Pharmaceuticals, Inc.
- Geographic Scope
- 1 states
Hazard Information
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 You Should Do
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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Full Description
Octreotide Acetate for Injectable Suspension, for gluteal intramuscular use, 30 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 0480-9262-08.. Generic: OCTREOTIDE ACETATE; Brand: OCTREOTIDE ACETATE. 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. Quantity: 21,930 Cartons. Distribution: Nationwide in the USA
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Product Classification
Product Details
Model Numbers
Lot:4400401
Exp.: 6/30/2026
4401393
4401494
4401604
+10 more
UPC Codes
0480-9257
0480-9259
0480-9262
+7 more
Affected States
ALL
Report Date
April 1, 2026
Source Agency
FDA - Drug SafetyRecall Status
ACTIVE
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