The Recall Desk
SevereFDA (Drugs)·D-0256-2017·Announced 2017-01-11

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.

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, 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
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.

See all 80 products in this recall →