FDA Recalls Sterile Injectable Drug Due to Quality Control Concerns
Oregon Compounding Centers is recalling sterile injectable drug vials due to quality control issues affecting sterility assurance.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a lack of sterility assurance in injectable products, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Oregon Compounding Centers, Inc. dba Creative Compounds is recalling all lots of sterile products compounded by the pharmacy that are not expired. The recall is due to concerns associated with quality control procedures that present a potential risk to sterility assurance, which were observed during a recent FDA inspection.
The specific product identified in the recall notice is PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial. The recall includes Lot # 20140901@3 with a discard date of 10/19/2014. The products were distributed in Oregon and Washington.
Consumers and healthcare providers should stop using the affected products and contact the recalling firm or their healthcare provider for further instructions.
The recalled product
- Product
- PAPAVERINE HCL/PHENTOLAMINE MES/ALPROSTADIL, 22mg/0.8mg/8mcg, injectable, 1.25 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
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)
- Lot #: 20140901@3
- discard date: 10/19/2014
Distribution
Part of a larger recall action
This product is one of 56 recalled by Oregon Compounding Centers, Inc. dba Creative Compounds under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 56 products in this recall →Related recalls
Same manufacturer · Oregon Compounding Centers, Inc. dba Creative Compounds
See all →- SevereGanciclovir Syringes Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Injectable Methycobalamin Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereCreative Compounds Recalls Ceftazidime Syringes Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
- SevereFDA Recalls Vitamin B Complex Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-11-12
Same hazard · sterility assurance
See all →- HighArrowhead DE LLC Recalls Arrow-LOK Implants Due to Sterility Assurance Concerns
FDA (Devices) · 2026-08-26
- SevereChloraPrep One-Step Applicators Recalled for Potential Packaging Seal Defects
FDA (Drugs) · 2026-07-22
- SeverePemetrexed for Injection Recalled Due to Lack of Sterility Assurance
FDA (Drugs) · 2026-07-15
- SevereChloraPrep One-Step Applicators Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2026-07-08
- SevereArrow access trays and PSI kits contain recalled supplier drugs
FDA (Devices) · 2026-06-24