The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0325-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Vitamin D3 Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 662 vials of compounded Vitamin D3 100,000 Unit/mL in olive oil because the agency cannot assure the products are 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. According to the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is lacking.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 662 vials of Vitamin D3 100,000 Unit/mL in olive oil (30 mL). The recall is being conducted because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The FDA has classified this recall as Class II, which means use of the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

The products were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific lot codes listed in the recall notice and stop using the affected products. The FDA has not reported any illnesses or injuries associated with this recall.

The recalled product

Product
Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
662

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 (4)

  • 08152016C (02/11/2017)
  • 10042016A (03/02/2017)
  • 07282016D (01/24/2017)
  • 09092016A (03/02/2016).

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 →

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