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.
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 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
- 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.
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