Medaus Recalls Dexpantenol Vials Due to Lack of Sterility Assurance
Medaus, Inc. is recalling Dexpantenol 250mg/mL vials because the company cannot ensure the product is sterile. The recall covers vials 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 recall is classified as FDA Class II. According to the rubric, FDA Class II recalls with potential for significant injury or hospitalization (implied by the lack of sterility assurance in a medical product) are categorized as Severe (Score 4).
Plain-English summary
Medaus, Inc. is recalling Dexpantenol 250mg/mL with preservative (benzalkonium chloride 0.01%) 10mL vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product. The recall includes 1,110 mL in vials across eight specific lots, all with a beyond-use date of 06/14/16.
The affected product was distributed nationwide in the United States, as well as in Japan and New Zealand. The specific lot numbers involved are 160204-45, 160210-38, 160215-9, 160222-16, 160223-6, 160229-74, 160302-31, and 160307-27.
Consumers and healthcare providers should stop using the affected vials and contact Medaus, Inc. for instructions on how to return the product or obtain a replacement. This recall is classified as FDA Class II, indicating a reasonable probability that the use of the product could cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- DEXPANTHENOL 250MG/ML W/PRES. (BENZALKONIUM CHL 0.01%), 10ML Vials, MEDAUS PHARMACY
- Manufacturer
- Medaus, Inc.
- Category
- Drug — Sterile 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 (9)
- Lot #: 160204-45
- BUD: 06/14/16
- Lot #: 160210-38
- Lot #: 160215-9
- Lot #: 160222-16
- Lot #: 160223-6
- Lot #: 160229-74
- Lot #: 160302-31
- Lot #: 160307-27
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 · lack of sterility
See all →- HighRohto Cooling Eye Drops Max Strength Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- HighRohto Cooling Eye Drops Recalled Due to Lack of Assurance of Sterility
FDA (Drugs) · 2026-07-29
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-15
- SevereAzacitidine for Injection Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15