Green Valley Drugs Recalls Cyanocobalamin Injection Due to Sterility Failure
Green Valley Drugs is recalling Cyanocobalamin 1000 mcg/mL injection because testing revealed positive sterility results.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The recall is classified as FDA Class I, which is the highest level of recall for drugs and indicates a reasonable probability that use of the product will cause serious adverse health consequences or death.
Plain-English summary
Green Valley Drugs is recalling Cyanocobalamin 1000 mcg/mL injection, 30 mL MDV, manufactured in Henderson, NV. The recall involves 58 vials from Lot 20121126-H.
The recall was initiated after the company's testing laboratory reported positive sterility results for the product. This indicates that the injectable solution may not be sterile, which is a critical requirement for products intended for injection.
The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Cyanocobalamin 1000 mcg/ml, injection 30 mL, MDV, For Office Use Only, Green Valley Drugs, Manufactured by Green Valley Drugs, Henderson, NV.
- Manufacturer
- Green Valley Drugs
- Category
- Drug — Injectable
- Hazard
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 (1)
- Lot: 20121126-H
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by 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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