Agency classClass IIOur severity:Severe FDA (Drugs)·D-1701-2015·Announced 2015-09-23

FDA Recalls Morphine and Bupivacaine Compounded Solution Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Morphine, Bupivacaine, and Clonidine solution due to FDA inspection findings of GMP violations affecting 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 and involves a sterile injectable solution where GMP violations impact sterility, posing a risk of serious injury or death from infection, which aligns with the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.

Plain-English summary

The Compounding Pharmacy of America is recalling Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml Solution, Sterile, Preservative Free. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected product is a 44 ml sterile solution. The recall covers all lots distributed between November 2014 and May 2015, specifically including lots 03092015@14 and 04242015@54. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication. This recall is classified as Class II by the FDA.

The recalled product

Product: Morphine 25 mg/ml + Bupivacaine 20 mg/ml + Clonidine 2,000 mcg/ml 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
03092015@14
6/7/2015
04242015@54
7/23/2015

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