Tri-Immune Boost Injectable Recalled for Lack of Sterility Assurance
Olympia Compounding Pharmacy is recalling 2,260 vials of Tri-Immune Boost injectable supplement due to lack of sterility assurance. Distribution was nationwide, including Puerto Rico and US Virgin Islands.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility assurance failure. No illnesses or injuries have been reported in the source material, but sterility failures in injectable products represent a recognized risk of harm without yet-reported injury, meeting the High severity criterion.
Plain-English summary
Olympia Compounding Pharmacy has recalled 2,260 vials of Tri-Immune Boost Glutathione 200 mg/mL, Ascorbic Acid 200 mg/mL, and Zinc Sulfate 2.5 mg/mL in 30 mL multi-dose vials. The recall was initiated due to lack of assurance of sterility for the affected product lots.
The affected lots are B24D01-22 and B24C01-22, with a Beyond Use Date of 6/1/2022 (NDC 73198-0104-30). These vials were distributed nationwide in the USA, Puerto Rico, and US Virgin Islands.
Sterility assurance is critical for injectable pharmaceutical products, particularly multi-dose vials. Consumers and healthcare providers who have received these vials should not use them and should contact Olympia Compounding Pharmacy or their healthcare provider for guidance on disposal and alternatives.
The recalled product
- Product
- Tri-Immune Boost Glutathione 200 mg/mL Ascorbic Acid 200 mg/mL Zinc Sulfate 2.5 mg/mL Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0104-30
- Category
- Drug — Compounded Injectable
- Hazard
- Affected units
- 2,260
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 (2)
- Lots: B24D01-22
- B24C01-22 BUD: 6/1/2022
Distribution
Part of a larger recall action
This product is one of 53 recalled by Olympia Compounding Pharmacy dba Olympia 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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