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Serious riskFDA DrugClass II

Teva Octreotide Acetate injectable suspension recalled for sterility assurance defect

Teva Pharmaceuticals is recalling specific lots of Octreotide Acetate 30 mg injectable suspension due to quality control problems found at the manufacturer. The FDA identified deficiencies that mean the sterility of these vials cannot be guaranteed. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Teva recalls

What to do

  1. Check if you have one of the affected lot numbers (4400401, 4401393, 4401494, 4401604, 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006)
  2. Do not use recalled vials; contact your pharmacist or doctor immediately
  3. Ask your doctor or pharmacist for a replacement or alternative medication
  4. Return unused vials to your pharmacy for proper disposal
Official notice ↗

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 3 products — see all of them.

Details

Units affected
21,930 Cartons
Illnesses reported
None reported
Manufactured in
400 Interpace Pkwy Bldg A, Parsippany, NJ, United States
Classification
Class II
Recall number
D-0406-2026

In the FDA's words

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. Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer. Lot:4400401, Exp.: 6/30/2026; 4401393, 4401494, 4401604, Exp.: 9/31/2026; 4500564, 4500601, 4500707, 4500796, 4500859, 4500918, 4500919, 4501006, Exp.: 3/31/2027. Distribution: Nationwide in the USA Affected quantity: 21,930 Cartons
Hazard
Lack of Assurance of Sterility: Quality system deficiencies identified during a routine U.S Food and Drug Administration (FDA) inspection at the contract manufacturer.

3 products in this recall

The agency lists each product separately. Check every one you might have.

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