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, which corresponds to a 'Severe' rating under the rubric, particularly given the risk of sterility failure in an intrathecal (spinal) injection product.
Plain-English summary
The Compounding Pharmacy of America is recalling Fentanyl 5,000 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 44 ml sterile, preservative-free intrathecal solution. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot 03022015@82 (expiration 5/31/2015) and lot 03202015@69 (expiration 6/18/2015). The product was distributed nationwide.
Healthcare providers and patients should discontinue use of the recalled product. The source text does not specify a particular consumer action beyond the recall itself, but standard practice for sterile injectable recalls involves contacting the manufacturer or healthcare provider for guidance on disposal or replacement.
The recalled product
- Product
- Fentanyl 5,000 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 — Injectable
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
- 03022015@82
- 5/31/2015
- 03202015@69
- 6/18/2015
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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