Multi-event August 2012 FDA Recall Diazepam by Hospira Inc.
This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on August 28, 2012 for the product Diazepam. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-309-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
08-28-2012
05-08-2013
172,350 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
09-18-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Batch or Lot Expiration Information
Lot# Lot 17-100-EV and 17-399-EV
Affected Packages Involved in this Recall
Recall Number: D-308-2013
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial
08-28-2012
05-08-2013
26,100 vials
Recall Profile & Regulatory Data
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.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Hospira Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide and Puerto Rico
09-18-2014
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Preservative-Free MORPHINE Sulfate Injection, USP, 10 mg/10 mL (1 mg/mL) 10 mL vial, Rx only, HOSPIRA, INC, LAKE FOREST, IL 60045 USA NDC 0409-3815-12
Batch or Lot Expiration Information
Lot# Lot 15-065-DK, Exp 1SEP2013
