FDA Recalls Compounded Injectable Drug Formula F9 Due to CGMP Violations
The FDA is recalling Formula F9, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel monitoring protocols were not properly followed, which could allow contamination.
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 recall for a compounded injectable drug with manufacturing control failures. No illnesses or injuries have been reported, but the recall addresses a theoretical contamination risk resulting from inadequate monitoring of manufacturing conditions.
Plain-English summary
The FDA is recalling Formula F9, a compounded injectable medication containing papaverine, phentolamine, PGE, and atropine, manufactured by Olympia Compounding Pharmacy. Approximately 800 vials have been distributed nationwide.
The recall was issued because the manufacturer failed to properly investigate deviations from manufacturing standards prior to October 1, 2021. Specifically, environmental and personnel monitoring protocols did not meet required safety thresholds, creating potential for product contamination.
This product was distributed nationwide in the USA. Patients and healthcare providers should contact their healthcare provider or Olympia Compounding Pharmacy for more information about their prescription.
The recalled product
- Product
- Formula F9, Papaverine 0.9mg/ml . Phentolamine 0.1mg/ml . PGE 20mcg/mL Atropine 0.01mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC: 73198-0004-10
- Category
- Drug — Injectable / Compounded
- Affected units
- 800
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 (3)
- Lots: D41C19 BUD: 4/19/2022
- I42C13 BUD: 9/13/2022
- I42B13 BUD: 9/13/2022
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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