Preserved ascorbic acid recalled due to lack of sterility assurance
Olympia Compounding Pharmacy is recalling 7,420 vials of Preserved Ascorbic Acid due to lack of assurance of sterility. The injectable drug was distributed nationwide throughout the USA, Puerto Rico, and US Virgin Islands.
What this means for you
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 with a potential sterility defect. No illnesses or deaths have been reported, but sterility assurance failure in injectable drugs poses a risk of serious infection, meeting the criterion for risk-of-harm products without reported injury.
Plain-English summary
Olympia Compounding Pharmacy is recalling Preserved Ascorbic Acid 500 mg/mL in 30 mL multi-dose vials (NDC 73198-0079-30) due to a lack of assurance of sterility. Approximately 7,420 vials are affected by this recall.
Injectable drugs must maintain sterility to prevent microbial contamination that could cause serious infections in patients receiving the treatment.
The affected lots were distributed nationwide in the USA, Puerto Rico, and US Virgin Islands. Healthcare providers and patients with these lot numbers should discontinue use and consult with their healthcare provider for alternative options. Affected lot numbers include A24B2022, A24C05, A24C12-22, A24C18-22, and A24C20-22.
The recalled product
- Product
- Preserved Ascorbic Acid 500 mg/mL, Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0079-30
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Compounded Injectable
- Hazard
- lack-of-sterility-assurance
- contamination-risk
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 (5)
- Lots: A24B2022
- A24C05 BUD: 7/5/2022
- A24C12-22 BUD 7/12/2022
- A24C18-22 BUD: 7/18/2022
- A24C20-22 BUD: 7/20/2022
Distribution
Distributed nationwide across the United States.
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