Medaus Recalls Zinc Chloride Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Zinc Chloride 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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (infection) from a non-sterile medical product, which aligns with the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medaus, Inc. is recalling 500 mL vials of Zinc Chloride 10mg/mL in NaCl 0.29% (PF). The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is identified by Lot # 160120-57 with a beyond-use date of 07/18/16. The recall covers distribution in the United States, Japan, and New Zealand.
Consumers and healthcare providers should check their inventory for this specific lot number and stop using the product. They should contact Medaus, Inc. for further instructions on how to return or dispose of the recalled vials.
The recalled product
- Product
- ZINC CHLORIDE 10MG/ML IN NACL 0.29% (PF), 2ML Vials, 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 (2)
- Lot #: 160120-57
- BUD: 07/18/16
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.
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