Pitocin Injection
FDA Recall NDC 42023-116
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Pitocin (NDC 42023-116). A significant event, classified as Class III, was initiated on Jun 05, 2012 by Par Health Usa, Llc. The reported reason for this action was: "Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)"."
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 III Terminated
Labeling: Label Mix-up: Pitocin storage conditions should be labeled, "Store between 20¿ to 25¿C (68¿ to 77¿F)". Pitocin lot 225867 and part of Pitocin lot 231423 were labeled, "Store between 20¿ to 25¿C (28¿ to 77¿F)".
Jun 05, 2012
Jul 25, 2012
26100 vials
Recall Profile & Regulatory Data
Event ID
62013
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
JHP Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide and Puerto Rico
Termination Date
Nov 05, 2012
Product Description
Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Batch or Lot Expiration Information
Lot# Lot 231423, 255867
Affected Packages Involved in this Recall
42023-116-25Product
42023-116-01Product
42023-116-02Product
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.
