Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials due to a lack of assurance of sterility. The affected products were distributed in the U.S., Japan, and New Zealand.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II. According to the severity rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by sterility failure in injectable products) are classified as Severe (Score 4).
Plain-English summary
Medaus, Inc. is recalling Folic Acid 10mg/mL in NaCl (PF), 1mL vials. The recall is being conducted because of a lack of assurance of sterility. The specific product affected is identified by Lot # 151214-62 with a Beyond Use Date of 06/11/16.
The affected vials were distributed nationwide in the United States, as well as in Japan and New Zealand. The product quantity involved is 250 mL in vials.
Consumers and healthcare providers should stop using the affected product and contact Medaus, Inc. for further instructions or a refund. This recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- FOLIC ACID 10MG/ML IN NACL (PF), 1ML 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 #: 151214-62
- BUD: 06/11/16
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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