FDAFDA · Food and drugs·Recall number D-0781-2017
SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose vial, 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 # t12-19-2016@76, Exp 4/27/2017; t11-28-2016@114, Exp 5/28/2017; t11-29-2016@102, Exp 5/29/2017; t12-06-2016@98, Exp 6/6/2017; t12-22-2016@118, Exp 6/21/2017; t12-22-2016@119, Exp 6/21/2017; t02-06-2017@98, Exp 8/6/2017; t02-07-2017@60, Exp 8/7/2017; t02-21-2017@109, Exp 08/21/2017
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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