The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0248-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Ascorbic Acid Vials Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 201 vials of compounded Ascorbic Acid 500 mg/mL due to a lack of assurance of sterility.

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 agency classification is FDA Class II. According to the rubric, an FDA Class II recall involving a significant hazard like lack of sterility in a compounded drug is classified as Severe (Score 4), as it carries a risk of serious adverse health consequences.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 201 vials of Ascorbic Acid 500 mg/mL (50 mL) compounded by the pharmacy. The recall is being conducted because of a lack of assurance of sterility in the products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The distribution pattern is nationwide. Specific lot codes and expiration dates associated with the recall include 07192016WW (01/15/2017), 07152016G (01/11/2017), 08292016A (02/25/2017), and 10262016B (02/28/2017).

Consumers and healthcare providers should check their inventory for these specific lot codes and stop using the affected products. The source text does not provide specific instructions for disposal or return, but users should contact their pharmacist or the recalling firm for guidance.

The recalled product

Product
Ascorbic Acid 500 mg/mL (50 ML). Compounded by Tri-Coast Pharmacy.
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
201

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 (3)

  • 07152016G (01/11/2017)
  • 08292016A (02/25/2017)
  • 10262016B (02/28/2017).

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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