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

FDA recall notice · announced July 25, 2012 · Jhp Pharmaceuticals

Class III FDA/FSIS Class III: use is not likely to cause adverse health consequences.

The 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)".

Notes

Distribution: Nationwide and Puerto Rico
Lot/code information: Lot 231423, 255867
Quantity: 26100 vials
Status: Terminated
Products in this recall event:
- 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)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.