Reported Jul 25, 2012 · Terminated

Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only, Manufactured and Distributed by: JHP…

JHP Pharmaceuticals, LLC

Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: JHP Pharmaceuticals, LLC · 870 Parkdale Rd · Rochester, MI · 48307-1740

Is this the product you have?

  • Pitocin (Oxytocin Injection, USP) Synthetic 10 units per mL 10 mL, Rx only
  • Manufactured and Distributed byJHP Pharmaceuticals, LLC Rochester, MI 48307 NDC 42023-116-02
Lot codes and dates
    • Lot 231423
    • 255867
Amount recalled
26100 vials

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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 product is unlikely to cause harm, but it breaks a safety or labelling rule.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Nov 5, 2012 · Data as of Sep 19, 7:12 PM UTC

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