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)".
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
Lot numbers, UPCs & expiration codes
Lot 231423, 255867
Where it was sold
Nationwide and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1420-2012
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 5, 2012
- FDA report date
- Jul 25, 2012
- Quantity
- 26100 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- JHP Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-1420-2012, exactly as published.
Show all FDA fields
- City
- Rochester
- State
- MI
- Status
- Terminated
- Country
- United States
- Event ID
- 62013
- Address
- 870 Parkdale Rd
- Code information
- Lot 231423, 255867
- Postal code
- 48307-1740
- Report date
- Jul 25, 2012
- Product type
- Drugs
- Recall number
- D-1420-2012
- Classification
- Class III
- Recalling firm
- JHP Pharmaceuticals, LLC
- Product quantity
- 26100 vials
- Termination date
- Nov 5, 2012
- 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)".
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Jun 5, 2012
- Initial firm notification
- Letter
- Center classification date
- Jul 16, 2012