The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0277-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Mineral Mix Schrader Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader because the agency cannot assure the products are sterile. The recall covers products compounded between May and November 2016.

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 a compounded pharmaceutical product, which poses a significant risk of infection or serious injury.

Plain-English summary

Tri-Coast Pharmacy is recalling 36 vials of Mineral Mix Schrader, a compounded sterile product containing zinc chloride, vanadium, manganese, and other minerals. The recall was initiated because the U.S. Food and Drug Administration (FDA) cannot assure the sterility of the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes include 05182016B (expiration date 11/14/2016) and 08102016B (expiration date 12/31/2016). The products were distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for instructions on how to return or dispose of the medication.

The recalled product

Product
Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
36

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)

  • 08102016B (12/31/2016)

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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