FDA Recalls Papaverine/Phentolamine Injections Due to Sterility Concerns
The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine injections due to quality control concerns regarding sterility assurance identified during an FDA inspection.
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. Per the rubric, FDA Class II recalls involving significant quality control failures that compromise sterility (a critical attribute for injectable drugs) are categorized as Severe.
Plain-English summary
The Compounding Center at Blue Ridge is recalling all lots of Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units. This recall covers all sterile products compounded by the pharmacy within their expiry dates.
The recall was initiated due to concerns associated with quality control procedures observed during a recent FDA inspection. Specifically, the agency cited a lack of assurance of sterility for the affected products.
The recall is classified as FDA Class II. Consumers and healthcare providers should stop using the recalled products and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Papaverine/Phentolamine 30 mg/mL/2.0 mg/mL Inj, 5 mL units Rx Only, The Compounding Center at Blue Ridge, 2601 Blue Ridge Rd, Raleigh, NC 27607.
- Manufacturer
- Compounding Centre At Blue Ridge
- 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 (1)
- All Lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 5 recalled by Compounding Centre At Blue Ridge 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 5 products in this recall →Related recalls
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