The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1709-2015·Announced 2015-09-23

FDA Recalls Compounded Morphine, Fentanyl, and Baclofen Injection for Sterility Concerns

The FDA is recalling compounded morphine, fentanyl, and baclofen injections due to GMP violations that may compromise sterility. The recall covers lots distributed nationwide between November 2014 and May 2015.

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 categorized as Severe (Score 4) due to the risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

The U.S. Food and Drug Administration (FDA) is recalling specific lots of a compounded sterile injection containing Morphine 50 mg/ml, Fentanyl 3,000 mcg/ml, and Baclofen 450 mcg/ml. The product was manufactured by The Compounding Pharmacy of America in Knoxville, Tennessee. 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 sterile, preservative-free solution. The recall includes all lots distributed between November 2014 and May 2015. Specific lot codes identified in the recall notice are 03202015@57 (expiration date 6/18/2015) and 04242015@53 (expiration date 7/23/2015). The product was distributed nationwide.

Patients who have received this medication should contact their healthcare provider for guidance on alternative treatment options. Healthcare providers should stop using the recalled product and return it to the manufacturer or dispose of it according to local regulations. The FDA classifies 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 50 mg/ml + Fentanyl 3,000 mcg/ml + Baclofen 450 mcg/ml, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer
The Compounding Pharmacy of America
Category
Drug — Compounded Injectable
Hazard

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
  • 03202015@57
  • 6/18/2015
  • 04242015@53
  • 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 →

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Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility failure

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