The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0268-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls L-Tyrosine Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 50 vials of compounded L-Tyrosine 10 mg/mL because the products lack 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, which corresponds to a Severe severity score under the rubric for drug recalls involving potential health risks.

Plain-English summary

Tri-Coast Pharmacy is recalling 50 vials of L-Tyrosine 10 mg/mL (30 mL) compounded by the firm. The recall is being conducted because the products lack assurance of sterility.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Specific lot codes with expiration dates include 07292016A (01/25/2017), 07182016E (01/14/2017), 08222016A (02/28/2017), and 10192016A (10/22/2016). The products were distributed nationwide.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
L-Tyrosine 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Drug
Hazard
Affected units
50

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 (3)

  • 07182016E (01/14/2017)
  • 08222016A (02/28/2017)
  • 10192016A (10/22/2016)

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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