The Recall Desk
HighFDA (Drugs)·D-0813-2022·Announced 2022-05-04

Compounded Injectable Drug Recalled Due to Manufacturing Process Violations

Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication, due to CGMP deviations in environmental and personnel monitoring. Monitoring excursions were not properly investigated prior to October 2021.

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: This recall involves a compounded injectable medication where environmental and personnel monitoring procedures were not properly implemented, creating a risk of undetected contamination. No illnesses or injuries have been reported, but the quality control failure represents a risk-of-harm product as defined in the rubric.

Plain-English summary

Olympia Compounding Pharmacy is recalling 1,849 vials of RE-1, a compounded injectable medication containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and Alprostadil 200 mcg/mL. The affected vials are distributed nationwide and include 10 mL multi-dose vials (NDC 73198-0015-10) and 2.5 mL multi-dose vials (NDC 73198-0015-03). The affected lot numbers are E47B18 and E47C18 (both with beyond-use date of 5/18/2022) and H24G31 (beyond-use date of 8/31/2022).

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations at the compounding facility. Prior to October 1, 2021, environmental and personnel monitoring excursions were not being properly investigated. These monitoring procedures are critical quality control measures designed to detect potential contamination in compounded medications. The failure to properly investigate monitoring excursions represents a breakdown in the facility's manufacturing controls.

Patients who have been prescribed this medication should consult their healthcare provider or pharmacist before discontinuing use. Healthcare providers and pharmacies should identify and quarantine any remaining inventory matching the affected lot numbers and contact Olympia Compounding Pharmacy for further instructions.

The recalled product

Product
RE-1, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 200 mcg/mL, Packaged in a) 10 mL Multi-Dose vial, NDC 73198-0015-10; b) 2.5 mL Multi-Dose vial, NDC 73198-0015-03; Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • cgmp-violation
  • 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 (3)

  • Lots: a) E47B18 BUD: 5/18/2022
  • b) E47C18 BUD: 5/18/2022
  • H24G31 BUD: 8/31/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category