Agency classClass IIOur severity:Severe FDA (Drugs)·D-392-2013·Announced 2013-05-22

Green Valley Drugs Recalls Lipotropic Injection Due to Sterility Concerns

Green Valley Drugs is recalling Lipotropic With Vitamins, Carnitine, Chromium and Glutamine 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 products, 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 Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations, including Lipo W/Vitamin-Carn-Crom_Glut-30 mL. The product is prescription-only and was distributed nationwide. The specific lot number is 130305600AE, with an expiration date of 6/5/2013.

The recall was initiated due to a lack of assurance of sterility. The FDA noted that all sterile products compounded, repackaged, and distributed by this compounding pharmacy are affected due to concerns associated with the quality control processes and the inability to guarantee sterility.

Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The agency classification for this recall is Class II.

The recalled product

Product: Lipotropic With Vitamins, Carnitine, Chromium and Glutamine Injection, all strengths and all presentations including Lipo W/Vitamin-Carn-Crom_Glut-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 Injectable
Hazard: sterility-failure
infection-risk
Affected units: 19

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 (2)

Lot #: 130305600AE
Exp 6/5/2013

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 →

Same manufacturer · FVS Holdings, Inc. dba. Green Valley Drugs

See all →

Severe
Green Valley Drugs Recalls Alpha Lipoic Acid Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
Severe
Green Valley Drugs Recalls Phosphatidylcholine Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
Severe
FDA Recalls Acetylcysteine Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2013-05-22
Severe
Green Valley Drugs Recalls Thiamine Hydrochloride Injection Due to Sterility Concerns
FDA (Drugs) · 2013-05-22
Severe
Green Valley Drugs Recalls Folic Acid Injections Due to Sterility Concerns
FDA (Drugs) · 2013-05-22

Same hazard · sterility failure