The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-355-2013·Announced 2013-05-22

Green Valley Drugs Recalls Cyanocobalamin Injections Due to Sterility Concerns

Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection nationwide because the pharmacy could not ensure the products were sterile.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. 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 in injectable products, which poses a significant risk of serious injury or infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 6,292 vials of Cyanocobalamin Injection, including all strengths and presentations, due to a lack of assurance of sterility. The recall covers products compounded, repackaged, and distributed by the pharmacy, including Cyanocobalamin 1000mcg and Cyanocobalamin 1000 mcg/mL in various volumes.

The FDA classified this recall as Class II. The recall was initiated because of concerns associated with the quality control processes at the compounding pharmacy, which resulted in a lack of sterility assurance for the sterile products.

The affected products were distributed nationwide. Consumers and healthcare providers should stop using the recalled vials and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Cyanocobalamin Injection, all strengths and all presentations including a) Cyanocobalamin 1000mcg, b) Cyanocobalamin 1000 mcg/mL in 1 mL, 10 mL, and 30 mL and 1 mL Preservative Free, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable
Hazard
Affected units
6,292

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 (20)

  • Lot #: a) Cyanocobalamin 1000mcg: 20130214-C
  • Exp 5/14/2013
  • 20130220-B
  • Exp 5/20/2013
  • 20130226-D
  • Exp 5/26/2013
  • 20130226-E
  • 20130226-L
  • 20130125-E
  • Exp 4/25/2013
  • 20130125-D
  • 20130125-C
  • 20130125-F
  • 20130211-M
  • Exp 5/11/2013
  • 20130214-B
  • 20130221-D
  • Exp 5/21/2013
  • 20130225-K
  • Exp 5/25/2013

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.

See all 78 products in this recall →

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