Recalls / Class II
Class IID-0760-2017
Product
CHOL/IN/ME(L)/B6 10ML MDV 50/50/25/0.1MG/ML INJ, Injection, 50mg/50mg/25mg/0.1mg/mL, Rx only, 10mL Glass/Multiple Dose vial, Prepared by Key Compounding Pharmacy
- Affected lot / code info
- Lot # t02-06-2017@107, Exp 4/30/2017 Lot t02-06-2017@107, Expiry date 4/30/2017
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
- 1 vial
- 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-0760-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.