Octreotide Acetate Injection 50 mcg/mL Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 50 mcg/mL in single-dose vials due to lack of assurance of sterility. The recall affects specific lots distributed nationwide, including Puerto Rico.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility defect. Lack of assurance of sterility in a single-dose injection carries significant risk of infection and potential serious harm to patients, meeting the Severe classification criteria.
Plain-English summary
Teva Pharmaceuticals USA is recalling Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vials (NDC 0703-3301-01) due to lack of assurance of sterility.
The affected product includes Lot #31329169B, Lot #31329231B, with expiration date 06/2022. A total of 6,184 vials were distributed nationwide, including Puerto Rico.
Octreotide Acetate Injection is a prescription medication. Consumers or healthcare providers who have this product should stop using it and contact their pharmacy or healthcare provider for guidance on disposal or replacement. Healthcare facilities should quarantine remaining product and contact Teva Pharmaceuticals or their supplier for further instructions.
The recalled product
- Product
- Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3301-01
- Manufacturer
- Teva Pharmaceuticals USA
- Hazard
- sterility-defect
- infection-risk
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot #: 31329169B
- 31329231B
- exp. Date 06/2022
Distribution
Distributed nationwide across the United States.
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