Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius
Failed Impuities/Degradation Specifications
Recall notice
Failed Impuities/Degradation Specifications
Contact the company & request your remedy
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Source Page by GovInfoNow · govinfonow.com/recall/42849-fresenius-kabi-usa-llc-recalls-octreotide-acetate-injection-50-mcg · Recall date May 4, 2016 · FDA enforcement record: FDA #D-0866-2016
Cite this page
“Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius.” GovInfoNow, recall dated May 4, 2016. https://govinfonow.com/recall/42849-fresenius-kabi-usa-llc-recalls-octreotide-acetate-injection-50-mcg. Based on FDA recall #D-0866-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0866-2016%22&limit=1).
How to tell if you have this one
- Brand
Fresenius Kabi USA, LLC- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
Nationwide and Puerto Rico.
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0866-2016 | 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 63323-365-01.; Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16 | 355,150 vials |
| D-0867-2016 | 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; Lot # 6108831; Exp. 07/16 | 40,280 vials |
Contact Fresenius Kabi USA, LLC
We’ve drafted a message you can send Fresenius Kabi USA, LLC to request your refund or repair — edit it as you like.
Subject: Recall D-0866-2016 — Fresenius Kabi USA, LLC Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base) Hello, I own a Fresenius Kabi USA, LLC recalls OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0.05 mg/mL), 1 mL Single Dose Vial, Rx only, Manufactured by Fresenius that is covered by recall D-0866-2016 from Fresenius Kabi USA, LLC. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0866-2016 (May 4, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0866-2016 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.