Recalls / Class II
Class IID-0720-2017
Product
HCG *10ML* MDV 500U/ML INJ, Injection, 500u/mL, Rx only, 10 mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
- Affected lot / code info
- Lot # 01-20-2017@74, Exp 4/20/2017; t02-01-2017@123, Exp 5/3/2017; t02-03-2017@47, Exp 5/7/2017; t02-07-2017@70, Exp 5/10/2017; t02-13-2017@100, Exp 5/15/2017.
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
- 72 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-0720-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.