Multi-event February 2013 FDA Recall Diazepam by Hospira Inc.

This Multi-event Class II drug recall was voluntarily initiated by Hospira Inc. on February 26, 2013 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

D-314-2013 TERMINATED D-316-2013 TERMINATED D-315-2013 TERMINATED D-313-2013 TERMINATED

Recall Number: D-314-2013

Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
02-26-2013
Reported
05-15-2013
Quantity
259,050 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65077
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.
Hospira Inc.
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.
11-10-2014
Product Description About Product Description
Full technical description of the product.
Furosemide Injection, USP, 40 mg/4mL (10 mg/mL), 4 ml Single-Dose Vial, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-6102-04

Batch or Lot Expiration Information

Lot# Lot 20-564-DK Exp. 02/14

Affected Packages Involved in this Recall

0409-6102-19 Furosemide
0409-6102-02 Furosemide
0409-6102-18 Furosemide
0409-6102-04 Furosemide
0409-6102-20 Furosemide
0409-6102-10 Furosemide

Recall Number: D-316-2013

Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
02-26-2013
Reported
05-15-2013
Quantity
266,900 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65077
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.
Hospira Inc.
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.
11-10-2014
Product Description About Product Description
Full technical description of the product.
Sodium Acetate Injection, USP, 40 mEq/20 ml (2 mEq/mL) 20 mL Single-Dose Fliptop, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-7299-73

Batch or Lot Expiration Information

Lot# Lot 23-320-DK and 23-321-DK Exp. 11/14

Affected Packages Involved in this Recall

0409-7299-83 Sodium Acetate
0409-7299-73 Sodium Acetate

Recall Number: D-315-2013

Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
02-26-2013
Reported
05-15-2013
Quantity
139,200 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65077
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.
Hospira Inc.
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.
11-10-2014
Product Description About Product Description
Full technical description of the product.
QUELICIN (succinylcholine chloride) Injection, USP, 200 mg (20 mg/mL) 10 mL, Rx only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, , NDC 0409-6629-02

Batch or Lot Expiration Information

Lot# Lot 21-480-EV Exp.12/13

Affected Packages Involved in this Recall

0409-6629-12 Quelicin
0409-6629-02 Quelicin
0409-6970-10 Quelicin

Recall Number: D-313-2013

Reason for Recall
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Initiated
02-26-2013
Reported
05-15-2013
Quantity
114,000 vials

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
65077
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.
Hospira Inc.
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.
11-10-2014
Product Description About Product Description
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 05-585-EV Exp. 05/13

Affected Packages Involved in this Recall

0409-3213-11 Diazepam
0409-3213-12 Diazepam