Hydromorphone Hydrochloride
FDA Recall NDC 0409-3356
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
This product is EXCLUDED from the official NDC directory because the listing data was discontinued by the firm.
The FDA has identified 3 recorded enforcement report(s) associated with Hydromorphone Hydrochloride (NDC 0409-3356). A significant event, classified as Class II, was initiated on Aug 22, 2017 by Hospira, Inc.. The reported reason for this action was: "Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process."
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
Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Aug 22, 2017
Sep 27, 2017
115,370 vials
Recall Profile & Regulatory Data
Event ID
77956
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Pfizer Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
United States Nationwide (including Puerto Rico) and Singapore
Termination Date
Feb 19, 2023
Product Description
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1mL Single-use vial, packaged in cartons of 25 vials, Rx only, Hospira, Inc., Lake Forest, IL 60045 USA, NDC 0409-3365-11 (carton) and 0409-3365-01(vial)
Batch or Lot Expiration Information
Lot# Lot: 760853A
Affected Packages Involved in this Recall
0409-2552-11Product
0409-2552-01Product
0409-3356-11Product
0409-3356-01Product
0409-2540-11Product
0409-2540-01Product
0409-3365-11Product
0409-3365-01Product
0409-3365-10Product
0409-1283-03Product
0409-1283-31Product
0409-1312-03Product
0409-1312-30Product
0409-1304-03Product
0409-1304-31Product
Class I Terminated
Superpotent (Single Ingredient) Drug: The prefilled cartridge unit has been found to be overfilled and contain more than the 1 mL labeled fill volume.
Aug 15, 2012
Oct 31, 2012
216,880 cartridge units
Recall Profile & Regulatory Data
Event ID
62854
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
May 29, 2015
Product Description
HYDROmorphone HCl Injection, USP, 2 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1312-30, Barcode (01) 1 030409 131230 9 (carton), (01) 0 030409 131230 2 (cartridge unit).
Batch or Lot Expiration Information
Lot# Lot 12720LL, Exp 12/01/13
Affected Packages Involved in this Recall
0409-2552-11Product
0409-2552-01Product
0409-3356-11Product
0409-3356-01Product
0409-2540-11Product
0409-2540-01Product
0409-3365-11Product
0409-3365-01Product
0409-3365-10Product
0409-1283-03Product
0409-1283-31Product
0409-1312-03Product
0409-1312-30Product
0409-1304-03Product
0409-1304-31Product
Class I Terminated
Superpotent (Single Ingredient) Drug: Some of the prefilled cartridge units have been found to be overfilled and contain more than the 1 mL labeled fill volume.
May 12, 2012
Aug 15, 2012
223,750 prefilled cartridge units
Recall Profile & Regulatory Data
Event ID
61847
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Hospira Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide.
Termination Date
May 29, 2015
Product Description
HYDROmorphone HCl Injection, USP, 1 mg/mL, 1 mL fill in a 2.5 mL Carpuject prefilled cartridge unit, packaged in 10-count Carpujects per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1283-31, Barcode (01) 1 030409 128331 9 (carton), (01) 0 030409 128331 2 (cartridge unit).
Batch or Lot Expiration Information
Lot# 07547LL, Exp 07/01/13
Affected Packages Involved in this Recall
0409-2552-11Product
0409-2552-01Product
0409-3356-11Product
0409-3356-01Product
0409-2540-11Product
0409-2540-01Product
0409-3365-11Product
0409-3365-01Product
0409-3365-10Product
0409-1283-03Product
0409-1283-31Product
0409-1312-03Product
0409-1312-30Product
0409-1304-03Product
0409-1304-31Product
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.
