D-0738-2016 Class II Terminated
FDA drug recall D-0738-2016 was initiated by Hartley Medical Center Pharmacy, Incorporated on February 4, 2016 and is designated Class II. Reason for recall: Lack of Assurance of Sterility The recall status is terminated (terminated August 9, 2016). Affected quantity: 1 syringe.
Recall Details
- Product Type
- Drugs
- Report Date
- March 16, 2016
- Initiation Date
- February 4, 2016
- Termination Date
- August 9, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 syringe
Product Description
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 Pattern
Nationwide. No foreign distribution.
Code Information
BUD: 5/3/2016