D-0757-2017 Class II Terminated
FDA drug recall D-0757-2017 was initiated by Key Pharmacy and Compounding Center on April 18, 2017 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility. The recall status is terminated (terminated August 29, 2017). Affected quantity: 4 vials.
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
- 4 vials
Product Description
PGE1/PROCAINE 5ML MDV 40MCG/ML/0.1% INJ, Injection, 40mcg/mL, 0.1%, Rx only, 5 mL Glass/Multiple 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 # t11-28-2016@86, Exp 5/22/2017; t12-19-2016@73, Exp 5/22/2017