Agency classClass IIOur severity:Severe FDA (Drugs)·D-1707-2015·Announced 2015-09-23

FDA Recalls Compounded Sterile Morphine, Fentanyl, and Bupivacaine Solution

The Compounding Pharmacy of America is recalling a sterile compounded solution of morphine, fentanyl, and bupivacaine due to GMP violations that compromise 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 and involves a sterile injectable product where GMP violations compromise sterility assurance, posing a significant risk of serious injury or death from infection.

Plain-English summary

The Compounding Pharmacy of America is recalling a sterile, preservative-free solution containing morphine, fentanyl, and bupivacaine. 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 compounded sterile solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation, including lots expiring in June 2015.

Healthcare providers and patients should stop using the recalled product immediately. The lack of assurance of sterility poses a risk of infection or other adverse health consequences if the product is administered. Users should contact the recalling firm or their healthcare provider for further instructions on disposal or replacement.

The recalled product

Product: Morphine 50 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 25 mg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Injectable
Hazard: sterility-compromise
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 (7)

All lots distributed between November 2014 and May 2015
03092015@15
6/7/2015
04092015@69
6/8/2015
05012015@12
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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Same hazard · sterility compromise