The Recall Desk
HighFDA (Drugs)·D-0804-2022·Announced 2022-05-04

T-106 Injectable Drug Recalled for Manufacturing Control Deviations

Olympia Compounding Pharmacy is recalling T-106 injectable drug nationwide (4,129 vials) due to manufacturing control 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 for failure to investigate environmental and personnel monitoring excursions in injectable drug manufacturing. The failure to properly monitor manufacturing controls in a compounding pharmacy presents a risk-of-harm situation where no illnesses have been reported.

Plain-English summary

Olympia Compounding Pharmacy is recalling T-106 (papaverine 30 mg/mL, phentolamine 1 mg/mL, alprostadil 25 mcg/mL) nationwide. The recall affects 4,129 vials distributed throughout the USA.

The recall was issued because prior to October 1, 2021, the company failed to properly investigate environmental and personnel monitoring Out of Action Limit (OOAL) excursions during drug manufacturing. These excursions indicate that monitoring conditions exceeded acceptable limits without appropriate investigation and corrective action.

The affected product is supplied in two formulations: 10 mL multi-dose vials (NDC 73198-0013-10) and 5 mL multi-dose vials (NDC 73198-0013-05). Affected lot codes include E24510, E24610, H42H03, E24810, and H42203, with Beyond Use Dates ranging from May 10, 2022 to August 3, 2022.

Healthcare providers and patients should not use affected vials. Patients currently using this product should consult their healthcare provider immediately.

The recalled product

Product
T-106, Papaverine 30 mg/mL . Phentolamine 1 mg/mL . Alprostadil 25 mcg/mL, Packaged as a) 10 mL Multi-Dose vial, NDC: 73198-0013-10; b) 5 mL Multi-Dose vial, NDC 73198-0013-05; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Injectable
Hazard
  • sterility-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 (5)

  • Lots: a) E24510 BUD: 5/10/2022
  • E24610 BUD: 5/10/2022
  • b) H42H03 BUD: 8/3/2022
  • E24810 BUD: 5/10/2022
  • H42203 BUD: 8/3/2022

Distribution

Distributed nationwide across the United States.

Related recalls

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