June 2016 FDA Recall Diazepam by Hospira Inc.
D-1359-2016 - Crystallization
This Class II drug recall was voluntarily initiated by Hospira Inc. on June 23, 2016 for the product Diazepam. The FDA reported the reason for recall as crystallization. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1359-2016
Crystallization: Product contains particulate identified to be crystallized active ingredient.
06-23-2016
07-20-2016
373,850 tubes
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
08-31-2018
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Diazepam Injection USP 10mg/2mL (5 mg/mL, 2 mL), Rx only, Hospira Inc. Lake Forest, IL 60045, NDC 0409-1273-32
Batch or Lot Expiration Information
Lot# : 52610LL, Exp. 01 OCT 2016
Lot# : 57660LL, Exp. 01 MAR 2017
