Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns
Green Valley Drugs is recalling 244 vials of Folic Acid Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.
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, which corresponds to a Severe rating under the rubric for significant injury or property damage reports or high-risk contamination scenarios.
Plain-English summary
FVS Holdings, Inc. dba Green Valley Drugs is recalling 244 vials of Folic Acid Injection in all strengths and presentations. The affected products include Folic Acid 10 mg/mL 30 mL, Folic Acid PF 10 mg/mL 2 mL and 5 mL, Folic Acid 20 mg/mL 30 mL, and Folic Acid 5 mg/mL 5 mL, 10 mL, and 30 mL. The recall is being conducted nationwide.
The recall was initiated because of a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy. The FDA cited concerns associated with the facility's quality control processes as the reason for the action.
Consumers and healthcare providers should stop using the recalled Folic Acid Injection products and contact their healthcare provider for further instructions. The recall number is D-366-2013.
The recalled product
- Product
- Folic Acid Injection, all strengths and all presentations including a) Folic Acid 10 mg/mL 30 mL; b) Folic Acid PF 10 mg/mL 2 mL and 5 mL; c) Folic Acid 20 mg/mL 30 mL; d) Folic Acid 5 mg/mL 5 mL, 10 ml and 30 mL Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV
- Manufacturer
- FVS Holdings, Inc. dba. Green Valley Drugs
- Category
- Drug — Injectable Medication
- Affected units
- 244
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 (4)
- Lot #: a) Folic Acid 10 mg/30 mL: 20130204-D
- Exp 5/4/2013
- b) Folic Acid PF 10mg/mL 2 mL: 20130219-E
- Exp 5/15/2013
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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