OCTREOTIDE ACETATE INJECTION — Class II drug recall D-0867-2016
Terminated recall by Fresenius Kabi USA, LLC, reported 2016-06-01, distributed nationwide. Failed Impuities/Degradation Specifications
| Recall number | D-0867-2016 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fresenius Kabi USA, LLC, Lake Zurich, IL, United States |
| Recall initiated | 2016-05-04 |
| Classified | 2016-05-24 |
| Reported by FDA | 2016-06-01 |
| Terminated | 2017-01-23 |
| Distributed | Nationwide (US) |
| Quantity | 40,280 vials |
| Reason classes | specification failure |
| NDC | 63323-0365-04 |
| Lot numbers | 07/16, 6108831 |
Product
OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius Kabi USA, LLC, Schaumburg, IL 60173, NDC 63323-365-04
Reason for recall
Failed Impuities/Degradation Specifications
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0867-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.