Agency classClass IIOur severity:Severe FDA (Drugs)·D-1482-2015·Announced 2015-09-23

FDA Recalls Fentanyl and Bupivacaine Intrathecal Solution Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine 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. The hazard involves a lack of assurance of sterility in an intrathecal (spinal) injection, which carries a significant risk of serious injury or infection if the product is contaminated.

Plain-English summary

The Compounding Pharmacy of America is recalling Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution. The product is a sterile, preservative-free solution with a total volume of 22 ml. The recall covers all lots distributed between November 2014 and May 2015, including specific codes 03092015@16 and 6/7/2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the solution is sterile. The product was distributed nationwide.

Healthcare providers and patients should stop using the recalled product immediately. Patients should consult their healthcare provider for alternative treatment options. The recalling firm is The Compounding Pharmacy of America, located in Knoxville, TN.

The recalled product

Product: Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Clonidine 1,300 mcg/ml + Baclofen 300 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Preparation
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 (3)

All lots distributed between November 2014 and May 2015
03092015@16
6/7/2015

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