Reported May 24, 2017 · Terminated
SOD PHENYLBUTYRATE SDV 30ML (CALIF or NEZ-CALIF) 200MG/ML INJ, Injection, 200mg/mL, Rx only, 30 mL Glass/Single Dose…
Key Pharmacy and Compounding Center
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Key Pharmacy and Compounding Center · 530 S 336th St · Federal Way, WA · 98003-6383
Is this the product you have?
- 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
- Lot codes and dates
9 of 9 products
Products covered by this recall # Product as published 1 Lot # t12-19-2016@76, Exp 4/27/2017 2 t11-28-2016@114, Exp 5/28/2017 3 t11-29-2016@102, Exp 5/29/2017 4 t12-06-2016@98, Exp 6/6/2017 5 t12-22-2016@118, Exp 6/21/2017 6 t12-22-2016@119, Exp 6/21/2017 7 t02-06-2017@98, Exp 8/6/2017 8 t02-07-2017@60, Exp 8/7/2017 9 t02-21-2017@109, Exp 08/21/2017 - Amount recalled
- 91 vials
This recall covers 79 products
The agency filed one notice per product. You are reading one of them; the other 78 are below.
66 more are in the archive.
Where it was sold
- Nationwide
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.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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