Tri-Coast Pharmacy Recalls Dexpanthenol Due to Sterility Concerns
Tri-Coast Pharmacy is recalling Dexpanthenol 250 mg/mL vials because the agency could not ensure the products were 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 medical products.
Plain-English summary
Tri-Coast Pharmacy is recalling 5 vials of Dexpanthenol 250 mg/mL (30 ML) compounded by the firm. The recall is being conducted because there is a lack of assurance of sterility for the affected products.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot code is 08162016B, with an expiration date of February 12, 2017. The products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled products and contact their pharmacist or the recalling firm for further instructions.
The recalled product
- Product
- Dexpanthenol 250 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 5
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 80 recalled by Tri-Coast Pharmacy 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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