The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-396-2013·Announced 2013-05-22

Green Valley Drugs Recalls Modified Myers Cocktail Injection Due to Sterility Concerns

Green Valley Drugs is recalling Modified Myers Cocktail Injection vials 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. According to the rubric, an FDA Class II recall involving a significant risk of harm (sterility failure in an injectable drug) corresponds to a severity score of 4 (Severe).

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 70 vials of Modified Myers Cocktail Injection. The recall includes all strengths and presentations, specifically Mod Meyer's Cocktail 37 mL and Modified Myers Cocktail 37 mL. The affected lots are 20130321-E (expiration 6/21/2013) and 20130215-F (expiration 5/15/2013). The products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The FDA identified concerns regarding the quality control processes used by the compounding pharmacy to compound, repackage, and distribute these sterile products.

Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Modified Myers Cocktail Injection, all strengths and all presentations including a) Mod Meyer's Cocktail 37 mL and b) Modified Myers Cocktail 37 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Injectable
Hazard
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 (4)

  • Lot #: a) 20130321-E
  • Exp 6/21/2013
  • b) 20130215-F
  • 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.

See all 78 products in this recall →

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