The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-384-2013·Announced 2013-05-22

Green Valley Drugs Recalls Magnesium Sulfate Injection Due to Sterility Concerns

Green Valley Drugs is recalling 529 vials of Magnesium Sulfate Injection 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 drugs, which poses a significant risk of serious injury or death from infection, meeting the criteria for a Severe rating.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 529 vials of Magnesium Sulfate Injection, including various strengths and presentations such as Magnesium Sulfate 50%, MAGNESIUM SULFATE 50% 50 mL, and Magnesium Sulfate PF 50% 2 mL. The recall is being conducted because the compounding pharmacy lacked assurance of sterility for all sterile products it compounded, repackaged, and distributed, along with concerns regarding its quality control processes.

The affected products were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation, including lots expiring between April 2013 and July 2013.

Consumers and healthcare providers should stop using the affected products and contact the recalling firm or their healthcare provider for further instructions.

The recalled product

Product
Magnesium Sulfate Injection, all strengths and all presentations including a) Magnesium Sulfate 50%; b) MAGNESIUM SULFATE 50% 50 mL, c) Magnesium Sulfate PF 50% 2 mL, 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
529

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 (18)

  • Lot #: a) Magnesium Sulfate 50%: 20130130-F
  • Exp 4/30/2013
  • 20130128-F
  • Exp 4/28/2013
  • 20130221-T
  • Exp 5/21/2013
  • b) MAGNESIUM SULFATE 50% 50 mL: 20130322-E
  • Exp 6/22/2013
  • 20130219-C
  • Exp 5/19/2013
  • 20130307-A
  • Exp 6/7/2013
  • 20130404-G
  • Exp 7/4/2013
  • c) Magnesium Sulfate PF 50% 2 mL: 20130227-F
  • Exp 5/27/2013
  • 20130312-G
  • Exp 6/12/2013

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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