Why it was recalled
Lack of Assurance of Sterility
Product description
Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Lot numbers, UPCs & expiration codes
BUD: 5/3/2016
Where it was sold
Nationwide. 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-0765-2016
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 4, 2016
- FDA report date
- Mar 16, 2016
- Quantity
- 1 syringe
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated
Original FDA data
Every field from FDA enforcement report D-0765-2016, exactly as published.
Show all FDA fields
- City
- Long Beach
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 73304
- Address
- 113 W Victoria St
- Code information
- BUD: 5/3/2016
- Postal code
- 90805-2162
- Report date
- Mar 16, 2016
- Product type
- Drugs
- Recall number
- D-0765-2016
- Classification
- Class II
- Recalling firm
- Hartley Medical Center Pharmacy, Incorporated
- Product quantity
- 1 syringe
- Termination date
- Aug 9, 2016
- Reason for recall
- Lack of Assurance of Sterility
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sufentanil Cit 50 mcg/ml/Clonidine HCL 1 mcg/ml/Bupivacaine HCL 5 mg/ml, vol. 20 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Distribution pattern
- Nationwide. No foreign distribution.
- Recall initiation date
- Feb 4, 2016
- Initial firm notification
- Telephone
- Center classification date
- Mar 4, 2016