The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-385-2013·Announced 2013-05-22

Green Valley Drugs Recalls Manganese Sulfate Injection Due to Sterility Concerns

Green Valley Drugs is recalling Manganese Sulfate Injection because the pharmacy could not ensure the sterility of the compounded products.

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. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectables) are rated as Severe (4).

Plain-English summary

FVS Holdings, Inc. dba Green Valley Drugs is recalling Manganese Sulfate Injection, all strengths and presentations, due to a lack of assurance of sterility. The recall covers 133 vials distributed nationwide. The specific products affected include Manganese-0.1 30 mL, Manganese Sulfate 0.1 mg/30 mL, and Manganese Sulfate 5 mg/5 mL.

The recall was initiated because the compounding pharmacy could not guarantee the sterility of the products it compounded, repackaged, and distributed. This decision was driven by concerns regarding the quality control processes at the facility.

Consumers and healthcare providers should stop using the affected Manganese Sulfate Injection products immediately. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
Manganese Sulfate Injection, all strengths and all presentations including a) Manganese-0.1 30 mL, b) Manganese Sulfate 0.1 mg/30 mL, c) Manganese Sulfate 5 mg/5 mg, 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
133

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 (8)

  • Lot #: a) Manganese-0.1 30 mL: 20130129500JN
  • Exp 4/29/2013
  • 1301302000AE
  • Exp 4/30/2013
  • b) Manganese Sulfate 0.1 mg/30 mL: 20130405-G
  • Exp 7/5/2013
  • c) Manganese Sulfate 5 mg/5 mL: 20130122-4
  • Exp 4/22/2013

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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