Drug recall D-1420-2012

Class III Terminated reported Jul 25, 2012

Product

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)".

Lots and codes

Lot 231423, 255867

Recall details

Recalling firm
JHP Pharmaceuticals, LLC, Rochester, MI
Quantity
26100 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
June 5, 2012
Terminated
November 5, 2012

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