The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-380-2013·Announced 2013-05-22

Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections nationwide due to a lack of assurance of sterility.

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 agency classified this as an FDA Class II recall. Under the rubric, an FDA Class II recall involving a significant safety hazard like lack of sterility assurance is categorized as Severe (Score 4).

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 209 vials of Lipotropic With Vitamin Injections. The recall covers all strengths and presentations, including Lipo W/ Vitamin 100 mL, Lipo W/ Vitamins 30 mL, Lipo W/Vitamin, and Lipo w/Vitamins #5 30 mL. These products are prescription-only and were distributed 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 quality control processes at the facility.

Consumers who have purchased these products should stop using them and contact their healthcare provider or the recalling firm for instructions on disposal or return.

The recalled product

Product
Lipotropic With Vitamin Injections, all strengths and all presentations including a) Lipo W/ Vitamin 100 mL, b) Lipo W/ Vitamins 30 mL, c) Lipo W/Vitamin, d) Lipo w/Vitamins #5 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV 89014.
Manufacturer
FVS Holdings, Inc. dba. Green Valley Drugs
Category
Drug — Compounded Sterile Injections
Hazard
Affected units
209

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 (13)

  • Lot #: a) Lipo W/ Vitamin 100 mL: 20130322-D
  • Exp 6/22/2013
  • 20130115-H
  • Exp 4/15/2013
  • b) Lipo W/ Vitamins 30 mL: 20130228-H
  • Exp 5/28/2013
  • 20130228-H
  • 20130322-D
  • 20130208-J
  • Exp 5/8/2013
  • c) Lipo W/Vitamin: 20130228-H
  • d) Lipo w/Vitamins #5 30 mL: 201301281000IN
  • Exp 4/28/2013

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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