The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0246-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Amino Energy Cocktail Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 59 vials of Amino Energy Cocktail because the agency cannot assure the sterility of the compounded product.

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 source text identifies the agency classification as Class II. According to the rubric, FDA Class II recalls are mapped to a severity score of 4 (Severe), particularly when involving sterile products where sterility assurance is lacking.

Plain-English summary

Tri-Coast Pharmacy is voluntarily recalling 59 vials of Amino Energy Cocktail (30 ML). The recall was initiated because the U.S. Food and Drug Administration (FDA) could not assure the sterility of the sterile compounded products.

The affected products were compounded between May 17, 2016, and November 17, 2016. The recall includes specific lot codes with expiration dates of November 28, 2016, and December 31, 2016. The products were distributed nationwide.

Consumers who possess these vials should stop using them and contact Tri-Coast Pharmacy for further instructions or a refund. The FDA classifies this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
59

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)

  • 07282016A (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 →

Related recalls

Same manufacturer · Tri-Coast Pharmacy

See all →

Same hazard · sterility failure

See all →

Similar recalls