Reported May 24, 2017 · Terminated

5-MTHF SDV 5MG/ML INJ, Injection, 5mg/mL, Rx only, packaged in 1 mL, 2 mL, 5 mL, and 10 mL Glass/Single Dose vials,…

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

Lot codes and dates: 8 of 8 products
Products covered by this recall
# Product as published
1 Lot # t12-05-2016@116, Exp 6/4/2017
2 t12-15-2016@84, Exp 6/14/2017
3 t12-23-2016@67, Exp 6/25/2017
4 t12-28-2016@105, Exp 6/27/2017
5 t01-30-2017@88, Exp 7/30/2017
6 t02-06-2017@109, Exp 8/6/2017
7 t02-14-2017@92, Exp 8/14/2017
8 t02-20-2017@79, Exp 8/20/2017
Amount recalled: 63 vials total (29/1 mL vials; 30/2 mL vials; 3/5 mL vials, and 1/10 mL vial)

The agency filed one notice per product. You are reading one of them; the other 78 are below.

66 more are in the archive.

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.

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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