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.
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 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.
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