FDAFDA · Food and drugs·Recall number D-0773-2017
PROCAINE HCL SDV 1% INJ, Injection, 1%, Rx only, packaged in 5mL and 50 mL Glass/Single Dose vials, Prepared by Key Compounding Pharmacy
Published May 24, 2017 · Recall initiated: April 18, 2017
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due to lack of assurance of sterility.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Key Pharmacy and Compounding Center
- Distributor
- Distributed nationwide in U.S.A., Australia and Canada.
- Lot
- Lot # t11-21-2016@115, Exp 5/21/2017; t11-23-2016@109, Exp 5/27/2017; t12-13-2016@94, Exp 6/12/2017; t01-19-2017@85, Exp 7/22/2017; 02/01/2017@116, Exp 7/31/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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