The Recall Desk
SevereFDA (Drugs)·D-0279-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Pyridoxine HCL Due to Sterility Concerns

Tri-Coast Pharmacy is recalling compounded Pyridoxine HCL 100 mg/ml vials because there is 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 recall is classified as FDA Class II and involves a lack of assurance of sterility in a drug product, which meets the rubric criteria for a Severe rating (FDA Class II with potential for serious injury).

Plain-English summary

Tri-Coast Pharmacy is recalling specific vials of compounded Pyridoxine HCL 100 mg/ml (30 ML) due to a lack of assurance of sterility. The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot code is 08162016A, with an expiration date of February 12, 2017.

The affected product consists of 3 vials per unit. The recall is classified as Class II by the U.S. Food and Drug Administration. The distribution pattern is listed as nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions or a replacement.

The recalled product

Product
Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Preparation
Hazard
Affected units
3

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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