The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0266-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls L-Arginine HCL Due to Sterility Concerns

Tri-Coast Pharmacy is recalling 41 vials of compounded L-Arginine HCL 100 mg/mL because there is a lack of assurance of sterility. The products were distributed nationwide.

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 sterile product, which poses a significant risk of infection or serious injury.

Plain-English summary

Tri-Coast Pharmacy is recalling 41 vials of L-Arginine HCL 100 mg/mL (30 mL) compounded by the firm. The recall is due to a lack of assurance of sterility in the sterile products.

The recall includes all sterile products compounded between May 17, 2016, and November 17, 2016. Known lot codes include 07282016H (expiration date 01/24/2017) and 09282016E (expiration date 03/27/2017). The products were distributed nationwide.

Consumers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
41

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)

  • 09282016E (03/27/2017)

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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