Agency classClass IIOur severity:Severe FDA (Drugs)·D-1609-2015·Announced 2015-09-23

Morphine and Clonidine Solution Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Morphine and Clonidine solution due to FDA inspection findings regarding 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, which corresponds to the 'Severe' severity level in the rubric, particularly given the risk of sterility failure in a sterile injectable medication.

Plain-English summary

The Compounding Pharmacy of America is recalling Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free. The recall involves 86 ml total volume units distributed nationwide between November 2014 and May 2015. Specific lot codes include 02272015@33 and 04012015@3.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency cited a lack of assurance of sterility as the primary reason for the action.

Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement.

The recalled product

Product: Morphine 50 mg/ml + Clonidine 100 mcg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Solution
Hazard: sterility-failure
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
02272015@33
5/28/2015
04012015@3
6/30/2015

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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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure