Why it was recalled
Lack of sterility assurance.
Product description
All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
Lot numbers, UPCs & expiration codes
All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
Where it was sold
Nationwide
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-0321-2018
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 30, 2017
- FDA report date
- Feb 14, 2018
- Quantity
- Unknown
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Intrathecal Compounding Specialist, LLC
Original FDA data
Every field from FDA enforcement report D-0321-2018, exactly as published.
Show all FDA fields
- City
- Scott
- State
- LA
- Status
- Terminated
- Country
- United States
- Event ID
- 78669
- Address
- 206 Jacobs Run
- Code information
- All lots remaining within expiry (BUDs between November 15, 2017 and December 16, 2017).
- Postal code
- 70583-8907
- Report date
- Feb 14, 2018
- Product type
- Drugs
- Recall number
- D-0321-2018
- Classification
- Class II
- Recalling firm
- Intrathecal Compounding Specialist, LLC
- Product quantity
- Unknown
- Termination date
- May 1, 2019
- Reason for recall
- Lack of sterility assurance.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583.
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 30, 2017
- Initial firm notification
- Letter
- Center classification date
- Feb 4, 2018