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.
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 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.
See all 53 products in this recall →Related recalls
Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy
See all →- HighLidocaine 2% injectable solution recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCompounded pharmaceutical vials recalled due to sterility assurance failure
FDA (Drugs) · 2022-06-01
- HighOndansetron Hydrochloride vials recalled due to sterility assurance concerns
FDA (Drugs) · 2022-06-01
Same hazard · sterility assurance failure
See all →- HighDELFLEX Peritoneal Dialysis Solution bags recalled for sterility risk
FDA (Drugs) · 2026-05-13
- SevereTirzepatide/Cyanocobalamin Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2025-07-02
- HighOmnicell IVX Station Reconstitution Transfer Sets Recall
FDA (Devices) · 2025-04-16
- HighCompounded Fentanyl and Bupivacaine Epidural Injections Recalled for Sterility Assurance
FDA (Drugs) · 2025-04-02
- HighHYDROmorphone Injectable Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2024-04-03
Similar recalls
- SevereFDA Recalls Calcium Chloride Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereCalcium Chloride Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2021-11-03
- SevereCantrell Drug Recalls Calcium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2016-12-21
- SevereRXQ Compounding Recalls Calcium Chloride Injection Due to Sterility Concerns
FDA (Drugs) · 2019-08-14
- HighCalcium Chloride Injectable Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2022-07-20
- SevereBella Pharmaceuticals Recalls Calcium Chloride Vials Due to Sterility Concerns
FDA (Drugs) · 2017-09-20