The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-416-2013·Announced 2013-05-22

Green Valley Drugs Recalls Zinc Sulfate Injection Due to Sterility Concerns

Green Valley Drugs is recalling 208 vials of Zinc 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 the hazard involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or infection.

Plain-English summary

FVS Holdings, Inc. dba. Green Valley Drugs is recalling 208 vials of Zinc Sulfate Injection, prescription only, in two presentations: 10 mg/mL 30 mL and 1 mg/mL 10 mL. The affected lots are 20130404-A (expiring 7/4/2013) and 20130206-B (expiring 5/6/2013). The products were distributed nationwide.

The recall was initiated due to a lack of assurance of sterility. The FDA cited concerns associated with the quality control processes used to compound, repackage, and distribute these sterile products.

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

The recalled product

Product
Zinc Sulfate Injection, all strengths and all presentations including a) Zinc Sulfate 10 mg/mL 30 mL and b) Zinc Sulfate 1 mg/mL 10 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
208

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) Zinc Sulfate 10 mg/30 mL: 20130404-A
  • Exp 7/4/2013
  • b) Zinc Sulfate 1 mg/10 mL: 20130206-B
  • Exp 5/6/2013 .

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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