The Recall Desk
HighFDA (Drugs)·D-0808-2022·Announced 2022-05-04

Injectable Drug SB-6 Recalled for Manufacturing Quality Control Deviations

Olympia Compounding Pharmacy recalls SB-6 injectable drug due to manufacturing deficiencies. Prior to October 2021, environmental and personnel monitoring procedures 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: This is an FDA Class II drug recall without reported hospitalizations or injuries. The deficiency involves inadequate manufacturing quality control monitoring. The recall of a pharmaceutical injectable product due to manufacturing quality control deviations constitutes a risk-of-harm situation where injury has not yet been reported.

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmacy is recalling SB-6, a multi-dose injectable pharmaceutical product containing Papaverine 30 mg/mL, Phentolamine 3 mg/mL, and PGE 60 mcg/mL. A total of 336 vials with lot numbers E41H18 (BUD 5/18/2022) and G41319 (BUD 7/19/2022) are affected. The product was distributed nationwide in the USA.

The recall was initiated due to manufacturing deficiencies related to Current Good Manufacturing Practice (CGMP) compliance. Prior to October 1, 2021, the facility did not properly investigate Out of Action Limit (OOAL) excursions in environmental and personnel monitoring protocols. This represents a quality control deviation in the manufacturing process.

Patients currently using this product should consult their healthcare provider or pharmacist immediately regarding their treatment. Do not discontinue use without medical guidance. Healthcare providers should check their inventory for the affected lot numbers and contact affected patients.

The recalled product

Product
SB-6, Papaverine 30 mg/mL . Phentolamine 3 mg/mL . PGE 60 mcg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0025-10.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • cgmp-deviation
  • 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 (2)

  • Lots: E41H18 BUD: 5/18/2022
  • G41319 BUD: 7/19/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category