Teva Octreotide Acetate Injection Recalled for Sterility Assurance Failure
Teva Pharmaceuticals is recalling Octreotide Acetate Injection 1000 mcg/5mL vials nationwide due to lack of assurance of sterility. The recall affects 16,644 vials distributed nationally.
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 a sterile injectable drug product. Lack of sterility assurance in multi-dose injectable medications poses a serious risk of infection if the product is administered, meeting the Severe classification criteria for Class II recalls involving injectable pharmaceuticals.
Plain-English summary
Teva Pharmaceuticals USA is recalling Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vials (NDC 0703-3333-01) due to lack of assurance of sterility. The affected lot is #31329150B with an expiration date of 06/2022. Approximately 16,644 vials were distributed nationwide, including Puerto Rico.
Octreotide acetate is a prescription medication used to treat certain medical conditions. A failure in sterility assurance means that the manufacturer cannot guarantee the product is free from microbial contamination, which could pose a risk to patients who receive the injection.
Patients currently taking this medication should contact their healthcare provider or pharmacist immediately to determine if they have received product from the recalled lot. Patients should not stop taking their medication without consulting their healthcare provider. Healthcare providers and patients with questions should contact Teva Pharmaceuticals USA or consult with their pharmacy regarding replacement product or alternative treatments.
The recalled product
- Product
- Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Teva Pharmaceuticals USA. Inc. North Wales, PA 19454, NDC 0703-3333-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Octreotide
- Affected units
- 16,644
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 (2)
- Lot #: 31329150B
- 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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