Compounded injectable drug recalled for manufacturing monitoring deviations
Olympia Compounding Pharmacy is recalling 388 vials of BIMIX-3 injection due to manufacturing process failures. Environmental and personnel monitoring excursions were not properly investigated prior to October 2021, raising concerns about product quality.
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: FDA Class II recall of a compounded injectable medication with manufacturing process deviations that violated sterility assurance monitoring requirements. No illnesses or injuries have been reported, but the quality monitoring failure raises potential contamination concerns in an injectable product, capping the severity at High.
Plain-English summary
BIMIX-3 is a compounded injection containing Papaverine 30 mg/mL and Phentolamine 3 mg/mL, manufactured by Olympia Compounding Pharmacy. The recalled product is a 10 mL multi-dose vial (NDC 73198-0027-10) from Lot F24C10 with a beyond-use date of June 10, 2022. Approximately 388 vials were distributed nationwide.
The recall is due to manufacturing process deviations that violate Current Good Manufacturing Practice (CGMP) standards. Prior to October 1, 2021, environmental and personnel monitoring excursions exceeded acceptable limits without proper investigation. These monitoring failures raise concerns about whether the product met required quality and sterility standards.
Healthcare providers and patients who have received this product should contact their healthcare provider to discuss any health concerns related to use. The product should not be administered to patients.
The recalled product
- Product
- BIMIX-3, Papaverine 30 mg/mL . Phentolamine 3 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0027-10.
- Category
- Drug — Compounded Injectable
- Affected units
- 388
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: F24C10 BUD: 6/10/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 34 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.
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