Agency classClass IIOur severity:High FDA (Drugs)·D-1481-2015·Announced 2015-09-23

Fentanyl and Clonidine Intrathecal Solution Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact sterility.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk product (intrathecal solution) with a risk of harm (lack of sterility) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Compounding Pharmacy of America is recalling Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The product was distributed nationwide between November 2014 and May 2015. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

This recall affects patients who received this specific intrathecal solution during the distribution period. The source text does not specify the number of units affected or report any illnesses or injuries. Consumers and healthcare providers should contact the recalling firm or their healthcare provider for further instructions on how to proceed with the recall.

The recalled product

Product: Fentanyl 100 mcg/ml +Clonidine 400 mcg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Intrathecal Solution
Hazard: sterility
gmp-violations

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 (3)

All lots distributed between November 2014 and May 2015
03092015@27
5/20/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility