Dextrose Injection, Solution
FDA Recall NDC 0409-1775
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Dextrose (NDC 0409-1775). A significant event, classified as Class II, was initiated on Nov 27, 2019 by Hospira, Inc.. The reported reason for this action was: "Labeling: Incorrect or Missing Lot and/or expiration date."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Labeling: Incorrect or Missing Lot and/or expiration date.
Nov 27, 2019
Dec 18, 2019
77,100 syringes
Recall Profile & Regulatory Data
Event ID
84366
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico.
Termination Date
Jan 14, 2022
Product Description
25% Dextrose Injection, USP 2.5 grams (250 mg/mL) 10 mL Single-dose, Rx Only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-1775-10
Batch or Lot Expiration Information
Lot# : 80-292-EV, 1AUG2019 on carton. Expiration date printed on syringe is 1AUG2021 which is incorrect.
Affected Packages Involved in this Recall
0409-1775-40Product
0409-1775-10Product
Class I Ongoing
Presence of Particulate Matter: human hair found within an internal sample syringe.
Apr 21, 2017
May 31, 2017
71,550 syringes
Recall Profile & Regulatory Data
Event ID
77111
Classification
Class I
Enforcement Status
Ongoing
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Product Description
Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Single-dose Syringe per carton, Rx only, Hospira Inc., Lake Forest, IL 60045, NDC 0409-1775-10
Batch or Lot Expiration Information
Lot# Lot 58382EV*, Exp 1OCT 2017, *lot may be followed by 01 or 02
Affected Packages Involved in this Recall
0409-1775-40Product
0409-1775-10Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
