The Recall Desk
HighFDA (Drugs)·D-0806-2022·Announced 2022-05-04

FDA Recalls Compounded Drug Due to Manufacturing Monitoring Deviations

Olympia Compounding Pharmacy is recalling SB-4 due to manufacturing quality control failures. The company did not properly investigate environmental and personnel monitoring problems that occurred before 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 a compounded pharmaceutical product where manufacturing quality control failures created a potential for contamination. Although no illnesses or injuries have been reported, the product represents a risk-of-harm situation meeting the criterion for High severity.

Plain-English summary

Olympia Compounding Pharmacy is recalling SB-4, a compounded injectable medication supplied in 10 mL multi-dose vials (National Drug Code 73198-0023-10). Approximately 1,740 vials have been distributed nationwide.

The recall was issued due to Current Good Manufacturing Practice (CGMP) violations. Prior to October 1, 2021, the manufacturer failed to properly investigate instances when environmental and personnel monitoring levels exceeded established action limits. These monitoring processes are essential for ensuring the safety and sterility of compounded medications.

The affected lot numbers are E41C18, E41D18, G42D20, and G42B20, with beyond-use dates ranging from May to July 2022. Patients and healthcare providers should not use this product. Anyone holding affected product should contact Olympia Compounding Pharmacy or their healthcare provider for guidance.

The recalled product

Product
SB-4, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . Alprostadil 40 mcg/mL, 10 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0023-10.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • cgmp-deviation
  • potential-contamination

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: E41C18 BUD: 5/18/2022
  • E41D18 BUD: 5/18/2022
  • G42D20 BUD: 7/20/2022
  • G42B20 BUD: 7/20/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category