Multi-event May 2016 FDA Recall Drug by Fresenius Kabi Usa, Llc

This Multi-event Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on May 4, 2016 for the product Drug. The FDA reported the reason for recall as failed impuities/degradation specifications. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0866-2016 TERMINATED D-0867-2016 TERMINATED

Recall Number: D-0866-2016

Reason for Recall
Failed Impuities/Degradation Specifications
Initiated
05-04-2016
Reported
06-01-2016
Quantity
355,150 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73811
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of 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.

Batch or Lot Expiration Information

Lot# 6108322; Exp. 04/16
Lot# 6108824; Exp. 07/16

Recall Number: D-0867-2016

Reason for Recall
Failed Impuities/Degradation Specifications
Initiated
05-04-2016
Reported
06-01-2016
Quantity
40,280 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
73811
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
01-23-2017
Product Description About Product Description
Full technical description of 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 63323-365-04

Batch or Lot Expiration Information

Lot# 6108831; Exp. 07/16