Drug 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
D-1420-2012
Product summary
- Event
- Event 62013
- Status
- Terminated
- Classification
- Class III
- Quantity
- 26100 vials
- Official record key
drug-enforcement:D-1420-2012
Official wording
Reason: 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)".
Code information: Lot 231423, 255867
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Labeling or packaging
Labeling: Label Mix-up