The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-395-2013·Announced 2013-05-22

Green Valley Drugs Recalls MIC Vitamin Injections Due to Sterility Concerns

Green Valley Drugs is recalling 588 vials and syringes of MIC Vitamin 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 and involves a lack of sterility assurance for 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 588 vials and syringes of MIC Vitamin Injection, including all strengths and presentations. The affected products were distributed nationwide. The recall is being conducted due to a lack of assurance of sterility for all sterile products compounded, repackaged, and distributed by the pharmacy, stemming from concerns associated with its quality control processes.

The recall covers specific lots of various MIC Vitamin Injection formulations, including MIC 25-50-25-30 mL, MIC_B_COMP-B12-25-50-50-1000-30 mL, and MIC_ULTRA-30 mL, among others. The source text does not specify reported illnesses or injuries associated with this recall.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product is found, it should be discontinued and returned to the supplier or disposed of according to local regulations. The FDA has classified this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
MIC Vitamin Injection, all strengths and all presentations including a) MIC 25-50-25-30 mL, b) MIC_B_COMP-B12-25-50-50-1000-30 mL, c) MIC_B12-25-50-25-400-30 mL, d) MIC_B6_B12-30 mL, e) MIC_METH_VIT-#3-30 m, f) MIC_METH-25-50-50-1000 mcg 30 mL, g) MIC_ULTRA-30 mL, h)…
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Injectable Compounded Drug
Hazard
Affected units
588

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) MIC 25-50-25-30 mL: 20130130-D
  • Exp 4/30/2013
  • 20130214-F
  • Exp 5/14/2013
  • b) MIC_B_COMP-B12-25-50-50-1000-30 mL: 1303261000AE
  • Exp 6/26/2013
  • c) MIC_B12-25-50-25-400-30 mL: 20130307-I
  • Exp 6/7/2013
  • 20120206-H
  • Exp 5/6/2013
  • d) MIC_B6_B12-30 mL: 20130208-E
  • Exp 5/8/2013
  • e) MIC_METH_VIT-#3-30 mL: 1302072000AE
  • Exp 5/7/2013
  • f) MIC_METH-25-50-50-1000 mcg 30 mL: 20130326-G
  • g) MIC_ULTRA-30 mL: 20130220-I
  • Exp 5/20/2013
  • h) MIC_VIT_METH_CARN-12.5-25-25-1-25-30 mL: 1302081000AE
  • 20130327-C
  • Exp 6/27/2013

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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