Recalls / Class II
Class IID-0786-2017
Product
VITAMIN D3 IN OLIVE OIL SDV 100,000U/ML INJ, Injection, 150,000u/mL, Rx only, packaged in 2mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
- Affected lot / code info
- Lot # t01-31-2017@119, Exp 5/2/2017; t02-01-2017@130, Exp 5/4/2017
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
- 5/2 mL 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-0786-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.