Olympia Pharmacy Recalls AT-1 Injectable Drug Due to Manufacturing Deviations
Olympia Compounding Pharmacy is recalling AT-1 injectable medication due to manufacturing control violations. Environmental and personnel monitoring failures may have affected product quality.
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 of an injectable medication with manufacturing control deviations affecting environmental monitoring. While no illnesses have been reported, the hazard is concerning given injectables require strict sterility controls.
Plain-English summary
Olympia Compounding Pharmacy is recalling AT-1 injectable medication (Papaverine 8mg/ml, Phentolamine 2mg/ml, Atropine 0.2mg/ml) distributed nationwide. The recall affects 310 vials from lots F41C28 and F41B28 (both expiring 6/28/2022).
The recall was issued because prior to October 1, 2021, the manufacturer did not properly investigate environmental and personnel monitoring deviations that exceeded acceptable limits. These monitoring failures could have affected the quality and safety of the product.
Patients should not use recalled medication without consulting their healthcare provider. Healthcare providers should identify and remove recalled product from stock. Patients who received this medication should contact their healthcare provider if they have concerns about safety.
The recalled product
- Product
- AT-1, Papaverine 8mg/ml . Phentolamine 2mg/ml . Atropine 0.2mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0039-10
- Manufacturer
- Olympia Compounding Pharmacy dba Olympia Pharmacy
- Category
- Drug — Injectable / Compounded
- Hazard
- manufacturing-deviation
- contamination-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 (2)
- Lots: F41C28 BUD: 6/28/2022
- F41B28 BUD: 6/28/2022
Distribution
Distributed nationwide across the United States.
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