Calcium Chloride Injectable Recalled for Sterility Assurance Concerns
Olympia Compounding Pharmacy is recalling 5,443 vials of Calcium Chloride 10% injectable due to lack of sterility assurance. The medication was distributed nationwide.
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 for lack of sterility assurance in an injectable pharmaceutical product. No illnesses or injuries have been reported. Per the rubric, a risk-of-harm product where injury has not yet been reported scores 3 (High).
Plain-English summary
Olympia Compounding Pharmacy is recalling 5,443 vials of Calcium Chloride 10% (100 mg/mL) in 30 mL multi-dose vials due to lack of assurance of sterility. This injectable medication was distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.
The affected lots are: B24C21-22 (BUD 8/21/2022), B24B21-22 (BUD 8/21/2022), A24010-22 (BUD 7/10/2022), and A24110-22 (BUD 7/10/2022). Healthcare providers who have received this medication should quarantine remaining vials and contact Olympia Compounding Pharmacy regarding return or destruction of the product. Patients who have been administered this medication should contact their healthcare provider for guidance.
The recalled product
- Product
- Calcium Chloride 10% (100 mg/mL), Multi-Dose 30 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0064-30
- Category
- Drug — Compounded Injectable
- Affected units
- 5,443
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)
- Lots: B24C21-22 BUD: 8/21/2022
- B24B21-22 BUD: 8/21/2022
- A24010-22 BUD: 7/10/2022
- A24110-22 BUD: 7/10/2022
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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