Agency classClass IIOur severity:Severe FDA (Drugs)·D-1615-2015·Announced 2015-09-23

Morphine and Clonidine Solution Recalled for Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Morphine and Clonidine 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 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. According to the rubric, FDA Class II recalls with potential sterility issues in injectable products are categorized as Severe (Score 4), as they carry a risk of significant injury or infection, even if specific hospitalization reports are not explicitly detailed in the provided text snippet.

Plain-English summary

The Compounding Pharmacy of America is recalling Morphine 70 mg/ml + Clonidine 1,100 mcg/ml Solution, Sterile-Preservative Free. 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.

The affected product is a 44 ml total volume solution. All lots distributed between November 2014 and May 2015 are included in this recall. Specific lot codes identified in the source include 02232015@22 and 03202015@81. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product: Morphine 70 mg/ml + Clonidine 1,100 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
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
02232015@22
5/24/2015
03202015@81
6/18/2015

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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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility