FDA Recalls Fentanyl and Clonidine Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Fentanyl and Clonidine Intrathecal Solution because an FDA inspection found GMP violations that may have compromised the product's 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 recall is classified as FDA Class II and involves a sterile intrathecal solution where GMP violations potentially impact sterility, posing a risk of serious infection or injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal Solution, Sterile - Preservative Free. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 67 ml total volume solution. All lots were distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 03022015@3 (5/31/2015), 03202015@54 (6/18/2015), and 04172015@34 (6/16/2015).
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions. 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
- Fentanyl 17,500 mcg/ml + Clonidine 1,000 mcg/ml Intrathecal 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 (7)
- All lots distributed between November 2014 and May 2015
- 03022015@3
- 5/31/2015
- 03202015@54
- 6/18/2015
- 04172015@34
- 6/16/2015
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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