Tri-Coast Pharmacy Recalls Calcium Gluconate Injection Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection compounded between May and November 2016 due to a lack of assurance of sterility.
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 an injectable drug, which poses a significant risk of infection or serious injury.
Plain-English summary
Tri-Coast Pharmacy is recalling 12 vials of Calcium Gluconate 10% Injection (30 ML) due to a lack of assurance of sterility. The recall includes all sterile products compounded by the pharmacy between May 17, 2016, and November 17, 2016. The known lot code is 08172016A, with an expiration date of February 13, 2017.
The affected products were distributed nationwide. This recall is classified as Class II by the U.S. Food and Drug Administration. The source text does not report any specific illnesses or injuries associated with the use of these products.
Healthcare providers and patients should stop using the recalled vials and contact Tri-Coast Pharmacy for further instructions or a replacement. Consumers should verify the lot code and expiration date against the information provided in this notice to determine if their product is affected.
The recalled product
- Product
- Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Category
- Drug — Injectable
- Hazard
- Affected units
- 12
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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