Compounded Injectable Drug Recalled Due to Sterility Assurance Failure
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication, due to lack of sterility assurance. The recall affects 528 vials from Lot K24409.
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 drug recall for a compounded injectable with asserted lack of sterility assurance. The source does not report any illnesses or injuries. Per the rubric, this is a risk-of-harm product where injury has not been reported, meeting the criterion for High severity.
Plain-English summary
Olympia Compounding Pharmacy is recalling AT-6, a compounded injectable medication containing Papaverine 40 mg/mL, Phentolamine 4 mg/mL, and Atropine 0.3 mg/mL in multi-dose 10 mL vials. The recall involves 528 vials from Lot K24409 (BUD 11/9/2022) due to lack of assurance of sterility.
The affected product was distributed nationwide in the United States, Puerto Rico, and the U.S. Virgin Islands. This is a prescription-only product for which sterility is a critical manufacturing requirement.
Healthcare providers and facilities that received this lot should stop dispensing and using the product. Patients who received treatment from this lot should contact their healthcare provider if they develop any signs of infection and consult Olympia Compounding Pharmacy or the FDA for guidance on returns or other appropriate actions.
The recalled product
- Product
- AT-6 Papaverine 40 mg/mL Phentolamine 4 mg/mL Atropine 0.3 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835 NDC 73198-0040-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Hazard
- sterility-defect
- infection-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 (1)
- Lot: K24409 BUD: 11/9/2022
Distribution
Distributed nationwide across the United States.
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