The Recall Desk
HighFDA (Drugs)·D-0814-2022·Announced 2022-05-04

FDA Recalls Compounded Injectable Medication RE-2 Due to Manufacturing Deviations

Olympia Compounding Pharmacy is recalling 2,201 vials of RE-2, a compounded injectable medication, because environmental and personnel monitoring deviations 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 Class II recall involves CGMP deviations in manufacturing controls that create a risk of contamination in a sterile injectable product, though no illnesses have been reported. Per the severity rubric, risk-of-harm products without reported injury qualify for High severity (score 3).

Plain-English summary

Olympia Compounding Pharmacy is recalling 2,201 vials of RE-2, a compounded injectable medication (NDC 73198-0016-10). The product is supplied as 10 mL multi-dose vials containing papaverine, phentolamine, and alprostadil.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Environmental and personnel monitoring systems identified excursions (out-of-limit readings) prior to October 1, 2021, but these were not properly investigated as required by CGMP standards. Investigations of monitoring excursions are essential to identify root causes and prevent potential product contamination.

The recalled vials were distributed nationwide in the United States. The affected lot numbers are E42G11 (beyond-use date 5/11/2022), H41003 (beyond-use date 8/3/2022), and H41B03 (beyond-use date 8/3/2022). NDC: 73198-0016-10.

Patients currently using this product should consult their healthcare provider. Unused vials should be returned to the pharmacy where they were dispensed.

The recalled product

Product
RE-2, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 300 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0016-10.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable Medication
Hazard
  • cgmp-violation
  • 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 (3)

  • Lots: E42G11 BUD: 5/11/2022
  • H41003 BUD: 8/3/2022
  • H41B03 BUD: 8/3/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category