Medaus Recalls Folic Acid Vials Due to Sterility Concerns
Medaus, Inc. is recalling specific lots of Folic Acid 10mg/mL vials because the company cannot ensure the product is sterile.
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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric for significant potential health risks such as sterility failures in injectable medications.
Plain-English summary
Medaus, Inc. is recalling 500 mL of Folic Acid 10mg/mL vials with preservatives. The recall is limited to Lot # 160215-30, which has a best-use date of 08/13/16. The product was distributed in the United States, Japan, and New Zealand.
The recall was initiated because the manufacturer lacks assurance of the product's sterility. This means the company cannot guarantee that the medication is free from microorganisms.
Consumers who have this specific lot of Folic Acid should stop using it and contact their healthcare provider or pharmacist for further instructions.
The recalled product
- Product
- FOLIC ACID 10MG/ML W/PRES. (METHYLPARABEN 0.05%, PROPYLPARABEN 0.025% IN NACL, 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable Medication
- 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 #: 160215-30
- BUD: 08/13/16
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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