D-1420-2012 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 25, 2012
- Initiation Date
- June 5, 2012
- Termination Date
- November 5, 2012
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 26100 vials
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
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)".
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot 231423, 255867