The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0255-2017·Announced 2017-01-11

Tri-Coast Pharmacy Recalls Calm Me Compounded Sterile Product Due to Sterility Concerns

Tri-Coast Pharmacy is recalling Calm Me compounded sterile products because there is a lack of assurance of sterility. The recall covers 10 vials 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 Calm Me, a compounded sterile product containing Aminobutyric Acid (GABA), Magnesium Chloride, Taurine, Theanine (L), Tryptophan (L), and Lidocaine HCL. The recall is being conducted due to a lack of assurance of sterility in the product.

The recall includes 10 vials of the 30 ML product. The affected products were compounded between May 17, 2016, and November 17, 2016. Known lot codes include 09212016A and 08032016C, both with an expiration date of January 31, 2017. The products were distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
Calm Me (Aminobutyric Acid (GABA) 50 mg/Magnesium Chloride 50 mg/Taurine 50 mg/Theanine (L) 50 mg/Tryptophan (L) 10 mg/Lidocaine HCL 10 mg/ml), (30 ML). Compounded by Tri-Coast Pharmacy.
Manufacturer
Tri-Coast Pharmacy
Category
Drug — Compounded Sterile Product
Hazard
Affected units
10

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)

  • 08032016C (01/31/2017).

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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