Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns
Green Valley Drugs is recalling Thiamine Hydrochloride Injection because the compounding pharmacy could not ensure the sterility of the products.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance for injectable drugs, which poses a significant risk of serious injury or death from infection.
Plain-English summary
FVS Holdings, Inc. dba. Green Valley Drugs is recalling Thiamine Hydrochloride Injection in all strengths and presentations. The recall includes Thiamine 100 mg/30 mL, Thiamine Hydrochloride 100 mg/mL with preservative 30 mL, Thiamine Hydrochloride 50 mg/mL with preservative 30 mL, and Thiamine Hydrochloride 100 mg/mL preservative free 10 mL and 30 mL. The affected quantity is 70 vials, and the products were distributed nationwide.
The recall was initiated due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the facility. The FDA identified concerns associated with the quality control processes at the compounding pharmacy.
Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- 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
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Category
- Drug — Injectable
- Affected units
- 70
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: a) Thiamine 100 mg/30 mL: 20130130-G
- Exp 4/30/2013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 78 recalled by FVS Holdings, Inc. dba. Green Valley Drugs under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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