Recalls / Class II
Class IID-0867-2016
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
- Affected lot / code info
- Lot # 6108831; Exp. 07/16
Why it was recalled
Failed Impuities/Degradation Specifications
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 40,280 vials
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2016-05-04
- FDA classified
- 2016-05-24
- Posted by FDA
- 2016-06-01
- Terminated
- 2017-01-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0867-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.