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.
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 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
- 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.
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