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.
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 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
- Affected units
- 528
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
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 defect
See all →- SevereLidocaine Hydrochloride Injection Recalled for Sterility Assurance
FDA (Drugs) · 2026-07-08
- SevereIMULDOSA injection recalled due to lack of sterility assurance
FDA (Drugs) · 2026-07-08
- HighChloraPrep One-Step antiseptic solution sterility assurance recall
FDA (Drugs) · 2026-07-01
- ModerateCodman CerebroFlo EVD Catheter recalled for out-of-specification endotoxin
FDA (Devices) · 2026-05-20
- SevereGenTeal Tears Lubricant Eye Gel Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-05-06
Similar recalls
- High
- HighFDA Recalls Compounded Injectable Drug Due to Manufacturing Control Failure
FDA (Drugs) · 2022-05-04
- HighOlympia Pharmacy Recalls AT-1 Injectable Drug Due to Manufacturing Deviations
FDA (Drugs) · 2022-05-04
- HighCompounded Injection Medication Recalled Due to Manufacturing Monitoring Deficiencies
FDA (Drugs) · 2022-05-04
- HighT-106 Injectable Drug Recalled for Manufacturing Control Deviations
FDA (Drugs) · 2022-05-04
- HighCompounding Pharmacy Recalls Injectable Medication Vials for Manufacturing Quality Failures
FDA (Drugs) · 2022-05-04