PlainRecalls
FDA Drug Moderate Class II Terminated

Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Reported: May 22, 2013 Initiated: April 10, 2013 #D-414-2013

Product Description

Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.

Reason for Recall

Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.

Details

Units Affected
70 vials
Distribution
Nationwide
Location
Henderson, NV

Frequently Asked Questions

What product was recalled? ▼
Thiamine Hydrochloride Injection, all strengths and all presentations including a) Thiamine 100 mg/30 mL, b) Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, c) Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, d) Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.. Recalled by FVS Holdings, Inc. dba. Green Valley Drugs. Units affected: 70 vials.
Why was this product recalled? ▼
Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 22, 2013. Severity: Moderate. Recall number: D-414-2013.

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