The Recall Desk
HighFDA (Drugs)·D-0799-2022·Announced 2022-05-04

T-105 Injectable Drug Recalled for Manufacturing Practice Deviations

Olympia Compounding Pharmacy is recalling T-105 injectables nationwide due to manufacturing process deviations. Environmental and personnel monitoring failures prior to October 2021 were not properly investigated.

What this means for you

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 an injectable compounded drug based on manufacturing control deviations. No illnesses or injuries are reported in the source, but the manufacturing process failure in environmental and personnel monitoring of an injectable product represents a risk-of-harm situation consistent with High severity.

Plain-English summary

Olympia Compounding Pharmacy is recalling T-105 (Papaverine 30mg/mL, Phentolamine 1mg/ml, and PGE 10mcg/ml) in 10ml, 5ml, and 2.5ml vials. Approximately 6,916 vials have been distributed nationwide in the United States. The product is a prescription-only injectable medication.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, excursions in environmental and personnel monitoring that exceeded allowable action limits were not being properly investigated.

Patients and healthcare providers who have received this product should consult with their healthcare provider regarding continued use. Patients should not discontinue use without medical guidance. Specific affected lot numbers and beyond-use dates are available from the FDA or the manufacturer.

The recalled product

Product
T-105, Papaverine 30mg/mL . Phentolamine 1mg/ml . PGE 10mcg/ml, , Packaged as a) 10 ml Multi-Dose vial, NDC 73198-0005-10; b) 5 ml Multi-Dose vial, NDC 73198-0005-05; c) 2.5 ml Multi-Dose vial, NDC 73198-0005-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlan
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • manufacturing-deviation
  • contamination-risk

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 (8)

  • Lots: a) D41412 BUD: 4/22/2022
  • E41F10 BUD: 5/10/2022
  • E41G10 BUD: 5/10/2022
  • F24D21 BUD: 6/21/2022
  • b) D41512 BUD: 4/12/2022
  • c) F42B21 BUD: 6/21/2022
  • H42B03 BUD: 8/3/2022
  • H42C03 BUD: 8/3/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category