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  3. Recall Enforcement Event ID: 73811

Recall Enforment Report D-0866-2016

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Fresenius Kabi USA, LLC, originally initiated on 05-04-2016 for the 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 63323-365-01. The product was recalled due to failed impuities/degradation specifications. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0866-201605-04-201606-01-2016Class II355,150 vialsOCTREOTIDE 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.Failed Impuities/Degradation SpecificationsTerminated
D-0867-201605-04-201606-01-2016Class II40,280 vialsOCTREOTIDE 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 63323-365-04Failed Impuities/Degradation SpecificationsTerminated