The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1253-2016·Announced 2016-07-20

Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Zinc Sulfate 1mg/mL vials because the company cannot ensure the product is 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 FDA classified this as a Class II recall. According to the rubric, an FDA Class II recall involving a significant risk of harm (lack of sterility in a medical product) corresponds to a severity score of 4 (Severe), as it is not a Class I recall but involves a serious potential hazard.

Plain-English summary

Medaus, Inc. is recalling Zinc Sulfate 1mg/mL (PF) 2mL vials due to a lack of assurance of sterility. The recall affects Lot #151217-38, which has an expiration date of 06/14/16. The product was distributed in the United States, Japan, and New Zealand.

The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences. The primary hazard is the potential for the product to be non-sterile, which poses a risk of infection if administered.

Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund. The recall is limited to the specific lot number and expiration date listed above.

The recalled product

Product
ZINC SO4 1MG/ML (PF), 2ML Vials, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Injectable
Hazard

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 #: 151217-38
  • BUD: 06/14/16

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 88 recalled by Medaus, Inc. 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 88 products in this recall →

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