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U.S. Department of Health and Human Services

Enforcement Report - Week of July 25, 2012

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Product Detail

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
Recall Number D-1420-2012
Classification Class III
Code Info Lot 231423, 255867
Product Distributed Qty 26100 vials
Reason For Recall 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)".

Event Detail

Event Id 62013
Product Type Drugs
Status Ongoing
Recalling Firm JHP Pharmaceuticals, LLC
City Rochester
State MI
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-06-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico