Recalls / Class II
Class IID-0774-2017
Product
PROCAINE HCL SDV 2% INJ, Injection, 2%, Rx only, packaged in 10mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
- Affected lot / code info
- Lot # t01-25-2017@122, Exp 4/26/2017; t12-12-2016@98, Exp 6/11/2017; t01-10-2017@119, Exp 7/10/2017
Why it was recalled
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Recalling firm
- Firm
- Key Pharmacy and Compounding Center
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 530 S 336th St, Federal Way, Washington 98003-6383
Distribution
- Quantity
- 9 vials total (3/10mL vials and 6/50mL vials)
- Distribution pattern
- Distributed nationwide in U.S.A., Australia and Canada.
Timeline
- Recall initiated
- 2017-04-18
- FDA classified
- 2017-05-17
- Posted by FDA
- 2017-05-24
- Terminated
- 2017-08-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0774-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.