The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0247-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Amino Acid Recover Eaze Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 105 vials of Amino Acid Recover Eaze 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 FDA classified this recall as Class II. According to the severity rubric, an FDA Class II recall involving a structural defect or significant risk (such as lack of sterility assurance) corresponds to a score of 4 (Severe), as it is not explicitly Class I but involves a serious potential hazard.

Plain-English summary

Tri-Coast Pharmacy is recalling 105 vials of Amino Acid Recover Eaze (50 ML) nationwide. The product contains Phenylaline (L), Tyrosine (L), and L-Taurine. The recall is being conducted because there is a lack of assurance of sterility for the affected products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes with expiration dates are 06072016C (11/15/2016) and 08162016E (09/08/2016). 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.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for further instructions on returns or replacements.

The recalled product

Product
Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
105

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)

  • 08162016E (09/08/2016).

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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