Recalls / Class II
Class IID-0767-2017
Product
GSH/NAC INH PV 150/50MG/ML SOLN, Inhalation Solution, 150mg/50mg/mL, Rx only, 4mL Plastic/Multiple Dose vial, Prepared by Key Compounding Pharmacy
- Affected lot / code info
- Lot # t02-21-2017@111, Exp 4/23/2017
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
- 180mL
- 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-0767-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.