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 identified during an FDA inspection.
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, which corresponds to a Severe severity score (4) under the rubric, as it involves a potential risk to sterility assurance that could lead to serious health consequences.
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 recall covers 1.7 mL glass vials containing 17.16mg Papaverine, 0.57mg Phentolamine, and 19.45mcg Prostaglandin. The specific lot number is 20140728@39, with a discard date of December 3, 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 sterile products. This issue affects all lots of sterile products compounded by the pharmacy that have not expired.
The affected products were distributed in Oregon and Washington. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.
The recalled product
- Product
- PAPAVERINE/PHENTOLAMINE/PROSTAGLANDIN, 17.16mg/0.57mg/19.45mcg, injectable, 1.7 mL glass vial, RX, Creative Compounds, Wilsonville, OR 97070
- Category
- Drug — Injectable
- Hazard
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 #: 20140728@39
- discard date: 12/3/2014
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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