The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0322-2017·Announced 2017-01-11

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

Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail nationwide due to 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 compounded drug, which poses a significant risk of infection or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

Tri-Coast Pharmacy is recalling 870 vials of Ultra Amino Energy Cocktail, a compounded sterile product containing various amino acids, vitamins, and lidocaine. The recall is being conducted because of a lack of assurance of sterility in the product.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring between November 2016 and May 2017.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 125mg/Thiamine HCL 50mg/Riboflavin-5-Phosphate Sod 5mg/Miacinamide 20mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 50mg/Chromium Picolinate…
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
870

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 (7)

  • 07272016C (11/30/2016)
  • 07152016H (11/30/2016)
  • 09152016B (12/31/2016)
  • 11022016B (05/01/2017)
  • 06082016B (11/30/2016)
  • 08172016C (12/31/2016)
  • 10202016C (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.

See all 80 products in this recall →

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