FDA Recalls Compounded Injectable for Lack of Sterility Assurance
Olympia Compounding Pharmacy recalls a multi-drug injectable compound (lot B41C22-22) due to inability to assure sterility. The recall affects 1,159 vials 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: FDA Class II recall of a high-risk injectable product with sterility assurance failure. Although no illnesses or injuries have been reported, the product inherently poses risk of harm to patients receiving injections from potentially non-sterile vials.
Plain-English summary
Olympia Compounding Pharmacy has recalled FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, a compounded injectable medication in multi-dose 10 mL vials. The affected lot is B41C22-22 with a beyond-use date of February 22, 2023. A total of 1,159 vials have been recalled.
The recall is due to lack of assurance of sterility. The manufacturer is unable to certify that the product meets the sterility requirements necessary for safe injection.
The product was distributed nationwide in the United States, Puerto Rico, and the US Virgin Islands. Patients and healthcare providers who have received this product should be aware of this recall.
Anyone who has received injections from vials in lot B41C22-22 should contact their healthcare provider. These vials should not be used.
The recalled product
- Product
- FA Papaverine 20 mg/mL Phentolamine 2 mg/mL Alprostadil 20 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, 6700 Olympia Pharmaceuticals, Conroy Rd., Ste. 155 Orlando, FL 32835, NDC 73198-0006-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- sterility-assurance-failure
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: B41C22-22 BUD: 2/22/2023
Distribution
Distributed nationwide across the United States.
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