Medaus Recalls Arginine Vials Due to Sterility Assurance Concerns
Medaus, Inc. is recalling specific lots of Arginine 100mg/mL vials because the company cannot assure 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 and involves a lack of sterility assurance for an injectable product, which poses a risk of serious injury or death, meeting the criteria for a Severe rating.
Plain-English summary
Medaus, Inc. is recalling Lot 151217-12 of Arginine 100mg/mL (PF), 10mL vials, with a best-use date of 06/14/16. The recall was initiated because the company lacks assurance of the sterility of the affected product.
The affected product was distributed in the United States, Japan, and New Zealand. The total quantity involved is 1,000 mL in vials.
Consumers and healthcare providers should stop using the recalled product and contact Medaus, Inc. for further instructions or a replacement.
The recalled product
- Product
- ARGININE 100MG/ML (PF), 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Injectable
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 #: 151217-12
- BUD: 06/14/16
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 →Related recalls
Same manufacturer · Medaus, Inc.
See all →- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Testosterone Cypionate Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Taurine Vials Due to Lack of Sterility Assurance
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls Lipo-Injection Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2016-07-20
- SevereMedaus Recalls B-Complex Vials Due to Sterility Concerns
FDA (Drugs) · 2016-07-20
Same hazard · infection
See all →- SevereSafeguard US Operating LLC Recalls Compression Bandages Due to Degradation
FDA (Devices) · 2026-10-14
- SevereStryker Bard EP XT Decapolar Steerable Diagnostic EP Catheter Recalled for Sterile Barrier Breach
FDA (Devices) · 2026-10-14
- HighEmbosphere Microspheres Recalled Due to Packaging Sterility Concerns
FDA (Devices) · 2026-10-07
- SevereAurolab Trust Recalls FOCUS PI Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2026-10-07
- HighFDA Recalls Defective Blue Nitrile Patient Examination Gloves
FDA (Devices) · 2026-10-07
Similar recalls
- SevereMedaus Recalls Taurine 50 mg/mL PF Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereMedaus Recalls Pyridoxine HCL Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereMedaus Recalls Magnesium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereMedaus Recalls L-Glutathione Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereMedaus Recalls NA Ascorbate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25
- SevereMedaus Recalls Sodium Ascorbate Injection Due to Sterility Concerns
FDA (Drugs) · 2013-09-25