Agency classClass IIOur severity:Severe FDA (Drugs)·D-405-2014·Announced 2014-01-15

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.

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. 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
Hazard: sterility
infection

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 →

Same manufacturer · Compounding Centre At Blue Ridge

See all →

Severe
Triple Mix Injectable Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2014-01-15
Severe
Quad Mix Injectable Recalled Due to Sterility Concerns
FDA (Drugs) · 2014-01-15
Severe
FDA Recalls Super Triple Mix Injectable Due to Sterility Concerns
FDA (Drugs) · 2014-01-15
Severe
FDA Recalls PGE Injectable Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-01-15

Same hazard · sterility