Agency classClass IIOur severity:Severe FDA (Drugs)·D-381-2013·Announced 2013-05-22

Green Valley Drugs Recalls Lipotropic Injections Due to Sterility Concerns

Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin 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 recall is classified as FDA Class II, which corresponds to a Severe rating (score 4) under the rubric, particularly given the risk of infection from non-sterile injections.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 176 vials of Lipotropic With Vitamins with Methylcobalamin Injections. The recall includes all strengths and presentations, specifically Lipo w/Vitamins-methylcobalamin 100 mL and 30 mL, and Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL. The affected 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. This action addresses concerns associated with the facility's quality control processes.

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

The recalled product

Product: Lipotropic With Vitamins with Methylcobalamin Injections, all strengths and all presentations including a) Lipo w/Vitamins-methylcobalamin 100 mL, 30 mL, and b) Lipo w/ Vitamins, Folic, Methylcobalamin 30 mL, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180, Henderson, NV…
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Compounded Injectable
Hazard: lack-of-sterility
infection-risk
Affected units: 176

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) Lipo w/Vitamins-methylcobalamin 100 mL: 20130225-A
Exp 5/25/2013
20130326-D
Exp 6/26/2013

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

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Same hazard · lack of sterility