Tri-Coast Pharmacy Recalls Glutathione Vials Due to Sterility Concerns
Tri-Coast Pharmacy is recalling 367 vials of compounded Glutathione 200 mg/mL nationwide because the products lack 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 FDA classified this recall as Class II, and the rubric specifies that FDA Class II recalls with potential for adverse health consequences (such as lack of sterility in injectable products) are categorized as Severe.
Plain-English summary
Tri-Coast Pharmacy is voluntarily recalling 367 vials of compounded Glutathione 200 mg/mL (30 mL) due to a lack of assurance of sterility. The recall covers all sterile products compounded between May 17, 2016, and November 17, 2016. The affected products were distributed nationwide.
The recall includes specific lot codes with expiration dates: 06082016A (09/06/2016), 07052016C (10/03/2016), 08082016A (11/06/2016), 09132016D (12/12/2016), and 10262016A (01/24/2016). The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Consumers and healthcare providers should stop using the affected products and contact Tri-Coast Pharmacy for further instructions or a refund. Patients should consult their healthcare provider if they have any concerns regarding the use of these compounded sterile products.
The recalled product
- Product
- Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy
- Manufacturer
- Tri-Coast Pharmacy
- Hazard
- Affected units
- 367
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 (4)
- 07052016C (10/03/2016)
- 08082016A (11/06/2016)
- 09132016D (12/12/2016)
- 10262016A (01/24/2016).
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.
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