Agency classClass IIOur severity:Severe FDA (Drugs)·D-1676-2015·Announced 2015-09-23

FDA Recalls Compounded Hydromorphone Fentanyl Bupivacaine Intrathecal Solution

The Compounding Pharmacy of America is recalling compounded intrathecal solution due to FDA inspection findings of GMP violations that impact sterility assurance.

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 and involves a sterile intrathecal injection where GMP violations impact sterility assurance, posing a significant risk of serious injury or infection.

Plain-English summary

The Compounding Pharmacy of America is recalling Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free. The recalled product is a 45 ml sterile solution manufactured in Knoxville, Tennessee, and distributed nationwide.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency has classified this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

All lots distributed between November 2014 and May 2015 are affected. Specific lot codes include 03122015@21 (expiration 6/10/2015) and 04092015@71 (expiration 6/8/2015). Patients and healthcare providers should contact their prescriber or the recalling firm for further instructions regarding the use of this medication.

The recalled product

Product: Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Injectable
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 (5)

All lots distributed between November 2014 and May 2015
03122015@21
6/10/2015
04092015@71
6/8/2015

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