FDA Recalls Compounded Injectable Drug Due to Manufacturing Control Failure
Olympia Compounding Pharmacy is recalling a multi-drug injectable product nationwide due to manufacturing control deviations. The facility failed to properly investigate environmental and personnel monitoring excursions prior to October 2021.
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 sterile injectable product with documented manufacturing control deviations affecting critical contamination safeguards. No contamination confirmed and no illnesses reported, but the risk-of-harm nature of a sterile injectable with control failures warrants a High severity rating.
Plain-English summary
Olympia Compounding Pharmacy, located in Orlando, Florida, is recalling a compounded injectable medication containing Papaverine, Phentolamine, Alprostadil, and Atropine. The recall affects 2,887 vials distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, the facility failed to properly investigate excursions in environmental and personnel monitoring—critical controls for ensuring the safety and sterility of injectable products. These deviations create a potential contamination risk.
Patients currently using products from the affected lots should contact their healthcare provider immediately. The affected lot numbers are F41414 (expiration 6/14/2022), F41C14 (expiration 6/14/2022), I24E28 (expiration 9/28/2022), and I24F28 (expiration 9/28/2022). Healthcare providers and patients should consult with their pharmacist regarding the status of prescriptions.
The recalled product
- Product
- FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20 mcg/mL . Atropine 0.2 mg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0006-10.
- Category
- Drug — Compounded Injectable
- Affected units
- 2,887
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 (4)
- Lots: F41414 BUD: 6/14/2022
- F41C14 BUD: 6/14/2022
- I24E28 BUD: 9/28/2022
- I24F28 BUD: 9/28/2022
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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