FDA recall D-0738-2016
Hartley Medical Center Pharmacy, Incorporated · Class II · drug
Product
Hydromorphone HCL 10 mg/ml/Baclofen 460 mcg/ml/Bupivacaine HCL, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
Reason for recall
Lack of Assurance of Sterility
Distribution
Nationwide. No foreign distribution.
Key facts
- Status
- Terminated
- Initiation date
- 2016-02-04
- Report date
- 2016-03-16
- Termination date
- 2016-08-09
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Long Beach, CA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0738-2016