The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-374-2013·Announced 2013-05-22

Green Valley Drugs Recalls Hydroxocobalamin Injection Due to Sterility Concerns

Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection nationwide due to a lack of assurance of sterility in its compounding and quality control processes.

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, which corresponds to a Severe rating under the rubric for significant injury risks or structural defects, even without reported fatalities.

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling 135 vials of Hydroxocobalamin Injection, prescription only, in all strengths and presentations. The affected products include Hydroxocobalamin 1000 mcg/mL 30mL and Hydroxocobalamin 1000 mcg/mL 10 mL P.F. The recall is being conducted nationwide.

The recall was initiated due to 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 affected vials and contact their pharmacist or the recalling firm for further instructions. The specific lot numbers identified in the recall are 20130321-C, 20130404-H, and 20130225-H.

The recalled product

Product
Hydroxocobalamin Injection, all strengths and all presentations including a) Hydroxocobalamin 1000 mcg/mL 30mL and b) Hydroxocobalamin 1000 mcg/mL 10 mL P.F., Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Sterile Product
Hazard
Affected units
135

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 (6)

  • Lot #: a) Hydroxocobalamin 1000 mcg/mL 30 mL: 20130321-C
  • Exp 6/21/2013
  • 20130404-H
  • Exp 7/3/2013
  • 20130225-H
  • 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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