The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1251-2016·Announced 2016-07-20

Medaus Recalls Zinc Sulfate Vials Due to Sterility Concerns

Medaus, Inc. is recalling specific lots of Zinc Sulfate 10mg/mL vials because the company cannot guarantee 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 recall is classified as FDA Class II. According to the rubric, an FDA Class II recall involving a significant risk such as lack of sterility in a medical product is categorized as Severe.

Plain-English summary

Medaus, Inc. is recalling specific lots of Zinc Sulfate 10mg/mL (PF) vials, 2mL size, due to a lack of assurance of sterility. The affected product is identified by the following lot numbers and expiration dates: Lot 151203-53 (BUD 05/31/16), Lot 151217-38 (BUD 06/14/16), and Lot 160208-36 (BUD 08/06/16).

The recall was initiated because the manufacturer could not ensure that the product remained sterile. The source text does not report any specific illnesses, injuries, or deaths associated with this recall.

The product was distributed nationwide in the United States, as well as in Japan and New Zealand. Consumers and healthcare providers should check their inventory for these specific lot numbers and stop using the product if it matches the recalled lots.

The recalled product

Product
ZINC SO4 10MG/ML (PF), Vials 2ML, MEDAUS PHARMACY
Manufacturer
Medaus, Inc.
Category
Drug — Pharmaceutical
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 (6)

  • Lot #: 151203-53
  • BUD: 05/31/16
  • Lot #: 151217-38
  • BUD: 06/14/16
  • Lot #: 160208-36
  • BUD: 08/06/16

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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