Octreotide Acetate Injectable Suspension Recalled Due to Sterility Assurance
Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension (30 mg) due to quality system deficiencies that affect sterility assurance. The recall affects all lots nationwide.
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 involving a sterility deficiency in an injectable drug product. Although no hospitalization reports are cited in the source text, an unsterile injectable poses a significant risk of serious infection, which meets the criteria for a Severe classification.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling 2,200 kits of Octreotide Acetate for Injectable Suspension, 30 mg, for intramuscular use, distributed nationwide. The product lot affected is 45011002, with expiration date 03/31/2027.
The recall was initiated due to a lack of assurance of sterility. Quality system deficiencies were identified during a routine U.S. Food and Drug Administration (FDA) inspection at the contract manufacturer, Pharmathen International S.A. in Greece.
Octreotide Acetate is a prescription injectable medication. Patients currently using this medication should contact their healthcare provider for guidance. Healthcare providers and pharmacists who have distributed this product should quarantine remaining inventory and contact Teva Pharmaceuticals USA, Inc. for instructions on return or disposal.
The recalled product
- Product
- OCTREOTIDE ACETATE (OCTREOTIDE ACETATE)
- Brand
- OCTREOTIDE ACETATE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Affected units
- 2,200
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: 45011002
- Exp. 03/31/2027
Distribution
Distributed nationwide across the United States.
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