Agency classClass IIOur severity:Severe FDA (Drugs)·D-1613-2015·Announced 2015-09-23

Morphine and Bupivacaine Solution Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Morphine and Bupivacaine 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. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable drugs are assigned a score of 4 (Severe) due to the risk of significant injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

The Compounding Pharmacy of America is recalling Morphine 64 mg/ml + Bupivacaine 10 mg/ml Solution, Sterile-Preservative Free. The product is a 33 ml total volume solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically identified by the code 04012015@4 with a date of 6/30/2015.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, leading to a lack of assurance that the product is sterile.

Consumers and healthcare providers who have this product should stop using it and contact the recalling firm for further instructions. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Morphine 64 mg/ml + Bupivacaine 10 mg/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 (3)

All lots distributed between November 2014 and May 2015
04012015@4
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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Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure