The Recall Desk
HighFDA (Drugs)·D-0948-2022·Announced 2022-06-01

Compounded injectable medication recalled for sterility assurance failure

Olympia Compounding Pharmacy is recalling QM-3, a multi-dose compounded injectable, due to lack of sterility assurance. The recall includes 414 vials distributed nationwide.

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 FDA Class II recall involves a sterile compounded injectable medication with documented lack of sterility assurance. Although no illnesses have been reported, the potential for serious harm from non-sterile injectable products classifies this as a high-risk situation.

Plain-English summary

Olympia Compounding Pharmacy dba Olympia Pharmaceuticals is recalling QM-3 (Papaverine 30 mg/mL, Phentolamine 3 mg/mL, Alprostadil 150 mcg/mL, and Atropine 0.2 mg/mL), a multi-dose 10 mL injectable vial distributed under NDC 73198-0019-10.

The recall was initiated due to lack of assurance of sterility in the compounded product.

A total of 414 vials (Lot A24505, beyond-use date January 5, 2023) were distributed nationwide in the USA, Puerto Rico, and the US Virgin Islands.

Patients who have received this product should consult with their healthcare provider about any health concerns.

The recalled product

Product
QM-3 Papaverine 30 mg/mL Phentolamine 3 mg/mL Alprostadil 150 mcg/mL Atropine 0.2 mg/mL, Multi-Dose 10 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0019-10.
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Compounded Injectable
Hazard
  • lack-of-sterility

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 (1)

  • Lot: A24505 BUD: 1/5/2023

Distribution

Distributed nationwide across the United States.

Related recalls

Same category