FDA Recalls Intrathecal Solution Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling a specific intrathecal solution because an FDA inspection found 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 product.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The recall is being conducted due to a lack of assurance of sterility.
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 sterile, preservative-free intrathecal solution. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot numbers 03022015@8, 5/31/2015, 03202015@60, 6/18/2015, and 04172015@29, 6/16/2015.
The product was distributed nationwide. Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions.
The recalled product
- Product
- Hydromorphone 45 mg/ml + Fentanyl 10,000 mcg/ml + Bupivacaine 15 mg/ml + Baclofen 720 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Intrathecal Solution
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@8
- 5/31/2015
- 03202015@60
- 6/18/2015
- 04172015@29
- 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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