Status
Terminated
Drug Enforcement D-1420-2012
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)".
Classification
Class III
Report Date
July 25, 2012
Termination Date
November 5, 2012
Product Information
- Product description
- 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
- Product quantity
- 26100 vials
- 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)".
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- JHP Pharmaceuticals, LLC
- Address
-
870 Parkdale Rd
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1420-2012
- Event ID
- 62013
- Recall initiation date
- June 5, 2012
- Center classification date
- July 16, 2012
- Code info
- Lot 231423, 255867
- More code info
- —