Why it was recalled
Lack of Assurance of Sterility
Product description
IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
Lot numbers, UPCs & expiration codes
Lot # 112621/E; Exp. 10/15
Where it was sold
AZ only. No foreign distribution.
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-0570-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 24, 2015
- FDA report date
- Jan 27, 2016
- Quantity
- 1 syringe
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Amerita Specialty Infusion Services
Original FDA data
Every field from FDA enforcement report D-0570-2016, exactly as published.
Show all FDA fields
- City
- Prescott
- State
- AZ
- Status
- Terminated
- Country
- United States
- Event ID
- 72967
- Address
- 1151 W Iron Springs Rd Ste J
- Code information
- Lot # 112621/E; Exp. 10/15
- Postal code
- 86305-1614
- Report date
- Jan 27, 2016
- Product type
- Drugs
- Recall number
- D-0570-2016
- Classification
- Class II
- Recalling firm
- Amerita Specialty Infusion Services
- Product quantity
- 1 syringe
- Termination date
- Feb 10, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614
- Distribution pattern
- AZ only. No foreign distribution.
- Recall initiation date
- Dec 24, 2015
- Initial firm notification
- Telephone
- Center classification date
- Jan 15, 2016