Olympia Compounding Pharmacy recalls T-50 injectable medication for manufacturing quality control deviations
Olympia Compounding Pharmacy is recalling T-50 injectable medication nationwide due to manufacturing quality control failures. Environmental and personnel monitoring controls were not properly investigated 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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II drug recall initiated as a precautionary measure due to quality control documentation and investigation failures. No illnesses or injuries reported. The recall addresses manufacturing process deficiencies rather than confirmed product contamination.
Plain-English summary
Olympia Compounding Pharmacy is recalling T-50, an injectable medication containing Papaverine 8 mg/mL, Phentolamine 0.29 mg/mL, and Alprostadil 2.9 mcg/mL. The recall affects 1,097 vials of this prescription medication that were distributed nationwide.
The recall was initiated due to current good manufacturing practice (CGMP) deviations identified at the manufacturer. Specifically, prior to October 1, 2021, environmental and personnel monitoring programs did not properly investigate excursions that exceeded established action limits. These failures represent deficiencies in manufacturing quality control systems.
Healthcare providers and patients who have received T-50 from affected lot numbers should contact Olympia Compounding Pharmacy or their healthcare provider for guidance. The affected lot numbers are: G24F01 (expiration 7/1/2022), G41316 (expiration 7/16/2022), H24B03 (expiration 8/3/2022), and H24C03 (expiration 8/3/2022).
If you have questions about this recall or have received this medication, contact your healthcare provider or pharmacist for appropriate medical advice.
The recalled product
- Product
- T-50, Papaverine 8 mg/mL . Phentolamine 0.29 mg/mL . Alprostadil 2.9 mcg/mL, 10ml Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0022-10.
- Category
- Drug — Injectable / Compounded
- Affected units
- 1,097
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: G24F01 BUD: 7/1/2022
- G41316 BUD: 7/16/2022
- H24B03 BUD: 8/3/2022
- H24C03 BUD: 8/3/2022
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.
See all 34 products in this recall →Related recalls
Same manufacturer · Olympia Compounding Pharmacy dba Olympia Pharmacy
See all →- HighLidocaine 2% injectable solution recalled for lack of sterility assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Testosterone Cypionate Injection Vials for Lack of Sterility Assurance
FDA (Drugs) · 2022-06-01
- HighCompounded pharmaceutical vials recalled due to sterility assurance failure
FDA (Drugs) · 2022-06-01
- HighOndansetron Hydrochloride vials recalled due to sterility assurance concerns
FDA (Drugs) · 2022-06-01
Same hazard · manufacturing defect
See all →- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighInjectable T-106 Vials Recalled Due to Sterility Assurance Deficiency
FDA (Drugs) · 2022-06-01
- HighFDA Recalls Compounded Papaverine Injection Due to Sterility Assurance
FDA (Drugs) · 2022-06-01
- ModerateOlympia Compounding Pharmacy recalls T-105 drug injection for potency issue
FDA (Drugs) · 2022-03-30
- HighCompounded Injectable Medication Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- HighFormula F2 Compounded Injectable Medication Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-06-01
- High