Medaus Recalls Hydrochloric Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of HCL 2MG/ML (PF) 5ML 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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of infection associated with non-sterile injectable products.
Plain-English summary
Medaus, Inc. is recalling HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY. The recall is being conducted because the company lacks assurance of the sterility of the product. The affected product is identified by Lot # 160111-62 with a Beyond Use Date (BUD) of 07/09/16.
The recalled product was distributed nationwide in the United States, as well as in Japan and New Zealand. The quantity involved is 1000 mL in Vials.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a return.
The recalled product
- Product
- HCL 2MG/ML (PF), 5ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Solution
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 #: 160111-62
- BUD: 07/09/16
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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