FDA Recalls Papaverine Injectable Due to Sterility Assurance Concerns
Oregon Compounding Centers is recalling Papaverine/Phentolamine/Prostaglandin injectable vials due to quality control issues affecting sterility assurance.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies a lack of sterility assurance in an injectable drug, which presents a potential risk of serious infection. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization potential are classified as Severe.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for Papaverine/Phentolamine/Prostaglandin injectable vials manufactured by Oregon Compounding Centers, Inc. dba Creative Compounds. The affected product is a 1.7 mL glass vial containing 17.64mg Papaverine, 0.58mg Phentolamine, and 5.8mcg Prostaglandin. The specific lot number is 20140828@4/1.7, with a discard date of October 15, 2014.
The recall was initiated due to a lack of sterility assurance. During a recent FDA inspection, quality control procedures were observed that present a potential risk to the sterility of the compounded products. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.
The product was distributed in Oregon and Washington. Patients who have received this medication should contact their healthcare provider for guidance on next steps. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.64mg/0.58mg/5.8mcg, injectable, 1.7 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 #: 20140828@4/1.7
- discard date: 10/15/2014
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 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
- SevereFDA Recalls Copper Sulfate Injectable Due to Sterility Assurance 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
Similar recalls
- SevereFDA Recalls Vital Care Compounder Papaverine and Prostaglandin Vials for Sterility Concerns
FDA (Drugs) · 2016-10-05
- HighCompounded Injectable Drug Recalled Due to Sterility Assurance Defect
FDA (Drugs) · 2022-11-09
- HighInjectable Drug Recalled Over Failure to Assure Product Sterility
FDA (Drugs) · 2022-11-09
- SevereFDA Recalls Compounded Papaverine-Phentolamine Injectable Due to Insanitary Conditions
FDA (Drugs) · 2019-04-17
- HighPharmacy Compounded Injection Recalled for Sterility Assurance Failure
FDA (Drugs) · 2022-11-09
- HighCompounded Injectable Medication Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2022-11-09