Recalls / Class III
Class IIID-1420-2012
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
- Brand name
- Pitocin
- Generic name
- Oxytocin
- Active ingredient
- Oxytocin
- Route
- Intravenous
- NDC
- 42023-116
- FDA application
- NDA018261
- Affected lot / code info
- Lot 231423, 255867
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)".
Recalling firm
- Firm
- JHP Pharmaceuticals, LLC
- Manufacturer
- Par Health USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 870 Parkdale Rd, Rochester, Michigan 48307-1740
Distribution
- Quantity
- 26100 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2012-06-05
- FDA classified
- 2012-07-16
- Posted by FDA
- 2012-07-25
- Terminated
- 2012-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1420-2012. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.