Agency classClass IIOur severity:Severe FDA (Drugs)·D-1483-2015·Announced 2015-09-23

FDA Recalls Fentanyl Intrathecal Solution Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Fentanyl intrathecal solution because an FDA inspection found GMP violations that may affect 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 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 potential sterility issues in injectable products are categorized as Severe (Score 4) due to the risk of serious injury or infection.

Plain-English summary

The Compounding Pharmacy of America is recalling Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution. The recall is due to a lack of assurance of sterility, as an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.

The affected product is a 66 ml total volume intrathecal solution. All lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 04062015@12, 04062015@35, and 05012015@50.

Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,300 mcg/ml + Baclofen 350 mcg/ml Intrathecal Solution, The Compounding Pharmacy of America Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Intrathecal Solution
Hazard: sterility
gmp-violation

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 (6)

All lots distributed between November 2014 and May 2015
04062015@12
7/5/2015
04062015@35
05012015@50
7/30/2015

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

See all →

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Same hazard · sterility