The Recall Desk
ModerateFDA (Drugs)·D-0820-2022·Announced 2022-05-04

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.

What this means for you

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.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • manufacturing-defect
  • quality-control-failure

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.

Related recalls

Same category