D-0780-2017 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2017
- Initiation Date
- April 18, 2017
- Termination Date
- August 29, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75 mL
Product Description
SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL Glass/Single Dose vial, Prepared by Key Compounding Pharmacy
Reason for Recall
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
Distribution Pattern
Distributed nationwide in U.S.A., Australia and Canada.
Code Information
Lot # 11-29-2016@27, Exp 5/20/2017; 01-25-2017@25, Exp 7/24/2017