FDA Recalls Compounded Sterile Pain Medication Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded sterile solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text identifies the recall as FDA Class II. Per the rubric, FDA Class II recalls are classified as Severe (Score 4), particularly when involving sterility issues in injectable medications which carry significant risk if compromised.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a recall for a compounded sterile solution manufactured by The Compounding Pharmacy of America in Knoxville, Tennessee. The product is a preservative-free solution containing morphine (50 mg/ml), fentanyl (2,000 mcg/ml), bupivacaine (10 mg/ml), and clonidine (200 mcg/ml). The recall involves 86 ml units distributed nationwide between November 2014 and May 2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency classifies this as a Class II recall, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Healthcare providers and patients who have received or used this specific compounded medication should contact their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Morphine 50 mg/ml + Fentanyl 2,000 mcg/ml + Bupivacaine 10 mg/ml Clonidine 200 mcg/ml, Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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
- 03162015@70
- 6/14/2015
- 04142015@72
- 5/20/2015
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.
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