Class III
Terminated
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
This recall has been terminated (originally issued July 25, 2012).
- Company
- Jhp Pharmaceuticals, Llc
- Recall Initiated
- June 5, 2012
- Posted
- July 25, 2012
- Recall Number
- D-1420-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 26100 vials
- Firm Location
- Rochester, MI, United States
- Official Source
- View on FDA website ↗
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
Nationwide and Puerto Rico
Lot / Code Info
Lot 231423, 255867
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