Tri-Coast Pharmacy Recalls B-Complex Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 67 vials of compounded B-Complex injections 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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or hospitalization.
Plain-English summary
Tri-Coast Pharmacy is recalling 67 vials of compounded B-Complex (30 ML) sterile injections. The recall was initiated because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the products. The affected product contains Thiamine HCL, Riboflavin-5-Phosphate, Pyridoxine HCL, Niacinamide, and Methylcobalamin.
The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The known lot codes are 07262016E (expiration date 12/31/2016) and 10262016E (expiration date 02/28/2017). The products were distributed nationwide.
Consumers and healthcare providers should stop using the recalled B-Complex vials immediately. They should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.
The recalled product
- Product
- B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy.
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Compounded Injectable
- Affected units
- 67
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 (1)
- 10262016E (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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