The Recall Desk
HighFDA (Drugs)·D-0801-2022·Announced 2022-05-04

Olympia Compounding Pharmacy Recalls AT-6 Injectable Drug Due to Manufacturing Control Deviations

Olympia Compounding Pharmacy is recalling AT-6 injectable drug due to manufacturing facility control failures. 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 is a FDA Class II recall involving manufacturing control deviations in a pharmaceutical facility. While no illnesses or injuries have been reported, the failure to properly investigate environmental and personnel monitoring excursions represents a significant risk-of-harm in drug manufacturing that warrants a High severity classification.

Plain-English summary

Olympia Compounding Pharmacy is recalling 1,318 vials of AT-6 (papaverine 40mg/ml, phentolamine 4mg/ml, and atropine 0.3mg/ml), a multi-dose injectable drug distributed nationwide in the United States.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Prior to October 1, 2021, the manufacturing facility failed to properly investigate excursions in environmental and personnel monitoring that exceeded action limits. These monitoring failures represent a breakdown in quality control procedures intended to ensure drug safety and consistency.

The affected lots are D41E20 (Beyond Use Date 4/20/2022), D41F20 (Beyond Use Date 4/20/2022), G41C13 (Beyond Use Date 7/13/2022), and G41B13 (Beyond Use Date 7/13/2022). Healthcare providers with this product should discontinue use and contact Olympia Compounding Pharmacy. No illnesses or adverse events have been reported.

The recalled product

Product
AT-6, Papaverine 40mg/ml . Phentolamine 4mg/ml . Atropine 0.3mg/ml, Multi-Dose 10 ml vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0040-10
Manufacturer
Olympia Compounding Pharmacy dba Olympia Pharmacy
Category
Drug — Injectable / Compounded
Hazard
  • manufacturing-control-failure
  • 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: D41E20 BUD: 4/20/2022
  • D41F20 BUD: 4/20/2022
  • G41C13 BUD: 7/13/2022
  • G41B13 BUD: 7/13/2022

Distribution

Distributed nationwide across the United States.

Related recalls

Same category