Recalls / Class II
Class IID-0744-2016
Product
Morphine Sulfate 20 mg/ml/Bupivacaine HCL 11.3 mg/ml, vol. 40 ml syringe, Rx only, Hartley Med Ctr Pharmacy, Long Beach, CA
- Affected lot / code info
- BUD: 5/3/2016
Why it was recalled
Lack of Assurance of Sterility
Recalling firm
- Firm
- Hartley Medical Center Pharmacy, Incorporated
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 113 W Victoria St, N/A, Long Beach, California 90805-2162
Distribution
- Quantity
- 1 syringe
- Distribution pattern
- Nationwide. No foreign distribution.
Timeline
- Recall initiated
- 2016-02-04
- FDA classified
- 2016-03-04
- Posted by FDA
- 2016-03-16
- Terminated
- 2016-08-09
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0744-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.