Octreotide Acetate Injection recall: Impurity Out of Spec
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…
Why was Octreotide Acetate Injection recalled?
Failed Impuities/Degradation Specifications
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot # 6108322; Exp. 04/16 Lot # 6108824; Exp. 07/16
- 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…
- Recalling firm
- Fresenius Kabi USA, LLC
- Quantity
- 355,150 vials
- Distribution
- Nationwide and Puerto Rico.
- Recall date
- June 1, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)