Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to FDA inspection findings of GMP violations that may impact 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 the source text explicitly states that GMP violations potentially impact product sterility, which is a significant safety risk for an intrathecal injection.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 129 ml total volume solution. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 02252015@14 (5/26/2015), 04012015@2 (6/30/2015), and 04272015@30 (7/26/2015).
Healthcare providers and patients should stop using the recalled product and contact The Compounding Pharmacy of America for further instructions on returns or replacements.
The recalled product
- Product
- Fentanyl 950 mcg/ml + Bupivacaine 5 mg/ml Intrathecal Solution, Sterile-Preservative Free,The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Intrathecal Solution
- 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
- 02252015@14
- 5/26/2015
- 04012015@2
- 6/30/2015
- 04272015@30
- 7/26/2015
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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