FDAFDA · Food and drugs·Recall number D-1420-2012
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
Published July 25, 2012 · Recall initiated: June 5, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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)".
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- PITOCIN
- Manufacturer
- JHP Pharmaceuticals, LLC
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot 231423, 255867
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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