The Recall Desk
SevereFDA (Drugs)·D-0321-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Ultra Amino Blend Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 79 vials of Ultra Amino Blend because the FDA determined there is a lack of assurance of sterility for the compounded product.

What this means for you

Illness, injury, or structural failure has been reported. 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. According to the rubric, FDA Class II recalls with potential for adverse health consequences are mapped to a severity score of 4 (Severe), as Class I is required for a score of 5.

Plain-English summary

Tri-Coast Pharmacy is recalling 79 vials of Ultra Amino Blend (30 mL) due to a lack of assurance of sterility. The product contains Arginine HCL, Lysine (L) HCL, Ornithine (L) HCL, Glutamine (L), and Lidocaine HCL. The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016.

The recall is classified as FDA Class II, indicating a situation where 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. The distribution of the affected product was nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions. Known lot codes include 06302016A, 06152016F, and 08152016D.

The recalled product

Product
Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
79

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 (2)

  • 06152016F (12/12/2016)
  • 08152016D (02/11/2017).

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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