Agency classClass IIOur severity:Severe FDA (Drugs)·D-372-2013·Announced 2013-05-22

Green Valley Drugs Recalls Hydrochloric Acid Injection Due to Sterility Concerns

Green Valley Drugs is recalling Hydrochloric Acid Injection products because of a lack of assurance of sterility and quality control concerns.

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 severity score under the rubric for significant injury risks or hospitalization reports.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling Hydrochloric Acid Injection, all strengths and all presentations. The affected products include Hydrochloric Acid 0.6%, Hydrochloric Acid 2%, Hydrochloric Acid Injection 0.06% 30 mL, and Hydrochloric Acid 2 mg/mL Injection 30 mL vial. The recall involves 63 vials 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 as the reason for the action.

Consumers and healthcare providers should stop using the affected products and contact their pharmacist or the recalling firm for instructions on return or disposal.

The recalled product

Product: Hydrochloric Acid Injection, all strengths and all presentations including a) Hydrochloric Acid 0.6%, b) Hydrochloric Acid 2%, c) Hydrochloric Acid Injection 0.06% 30 mL, d) Hydrochloric Acid 2 mg/mL Injection 30 mL vial, Rx only, Green Valley Drugs, 1850 Whitney Mesa, #180…
Manufacturer: FVS Holdings, Inc. dba. Green Valley Drugs
Category: Drug — Injectable
Hazard: sterility
infection
Affected units: 63

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) Hydrochloric Acid 0.6%: 20130212-H
Exp 5/12/2013
b) Hydrochloric Acid 2%: 2013012952000AE
Exp 4/29/2013 .

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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