The Recall Desk
HighFDA (Drugs)·D-0803-2022·Announced 2022-05-04

Compounded Injectable Drug Recalled for Manufacturing Control Failures

Olympia Compounding Pharmacy is recalling NB-243, a compounded injectable medication, due to manufacturing control failures. Environmental and personnel 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 is an FDA Class II recall for manufacturing control deviations in an injectable drug. Although no illnesses or injuries have been reported, the failure to properly investigate environmental and personnel monitoring excursions represents a significant quality control failure in injectable drug manufacture where contamination risks are inherently high.

Plain-English summary

Olympia Compounding Pharmacy is recalling NB-243, a compounded injectable medication containing Papaverine 30 mg/ml, Phentolamine 3 mg/ml, and Alprostadil 20 mcg/ml in 10 ml multi-dose vials. This is a prescription-only product manufactured by Olympia Compounding Pharmacy in Orlando, Florida.

The recall is due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated. These monitoring failures represent a breakdown in the manufacturing controls intended to detect and prevent contamination of injectable medications.

A total of 3,509 vials across four lot numbers were distributed nationwide in the USA. The affected lot numbers are I24C28 (BUD 9/28/2022), D41I19 (BUD 4/19/2022), F41321 (BUD 6/21/2022), and I24128 (BUD 9/28/2022).

The recalled product

Product
NB-243, Papaverine 30mg/ml . Phentolamine 3mg/ml . Alprostadil 20mcg/ml, 10ml Multi-Dose vials, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0009-10
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • manufacturing-control-failure
  • microbial-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 (4)

  • Lots: I24C28 BUD: 9/28/2022
  • D41I19 BUD: 4/19/2022
  • F41321 BUD: 6/21/2022
  • I24128 BUD: 9/28/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category