Compounded Injection Recalled Due to Manufacturing Process Monitoring Deviations
Olympia Compounding Pharmacy recalled Formula F2 injectable (257 vials) due to improper investigation of manufacturing monitoring excursions before October 1, 2021. The product was distributed nationwide.
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 for CGMP deviations in a compounded injectable medication. No illnesses or injuries are reported, so the hazard is theoretical. Per the rubric, risk-of-harm products without reported injury score 3.
Plain-English summary
Formula F2 is a compounded injectable medication containing papaverine, phentolamine, alprostadil, and atropine in a 10 mL multi-dose vial. Olympia Compounding Pharmacy issued a Class II recall of 257 vials (lots G48C20 and G48B20) distributed nationwide.
The FDA classified this recall due to Current Good Manufacturing Practice (CGMP) violations. Prior to October 1, 2021, the manufacturer failed to properly investigate environmental and personnel monitoring excursions that exceeded action limits.
Healthcare providers and patients with the recalled vials should not use them. Anyone who has received this medication should consult their healthcare provider.
The recalled product
- Product
- Formula F2, Papaverine 9 mg/mL . Phentolamine 1 mg/mL . Alprostadil 10 mcg/mL . Atropine 0.1 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0002-10.
- Category
- Drug — Compounded Injectable
- Affected units
- 257
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: G48C20 BUD: 7/20/2022
- G48B20 BUD: 7/22/2022
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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