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.
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 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
- 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.
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