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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 6,184
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
Part of a larger recall action
This product is one of 19 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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