Fentanyl and Bupivacaine Intrathecal Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Fentanyl and Bupivacaine Intrathecal Solution due to GMP violations that may impact sterility.
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 intrathecal product where GMP violations potentially impact sterility, posing a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 8,000 mcg/ml, + Bupivacaine 40 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 22 ml total volume intrathecal solution. All lots were distributed nationwide between November 2014 and May 2015. The specific lot code identified is 03242015@103, with a date of 6/22/2015.
Healthcare providers and patients should stop using the recalled product and contact the recalling firm or the FDA for further instructions. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Fentanyl 8,000 mcg/ml, + Bupivacaine 40 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 (3)
- All lots distributed between November 2014 and May 2015
- 03242015@103
- 6/22/2015
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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