FDA Recalls Compounded Intrathecal Pain Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded intrathecal pain solution because an FDA inspection found GMP violations that may affect 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. According to the rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is compromised is rated as Severe (4) due to the potential for significant injury from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling a specific compounded intrathecal solution containing hydromorphone, fentanyl, bupivacaine, clonidine, and baclofen. The product is a sterile, preservative-free solution intended for intrathecal administration.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns about the assurance of sterility and potentially impact the overall quality of the product.
The recall covers all lots distributed between November 2014 and May 2015. The distribution pattern is listed as nationwide. Patients who have received this medication should contact their healthcare provider for guidance on next steps.
The recalled product
- Product
- Hydromorphone 70 mg/ml+Fentanyl 16,000 mcg/ml+Bupivacaine 15 mg/ml+Clonidine 1,000 mcg/ml+Baclofen 900 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- 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 (5)
- All lots distributed between November 2014 and May 2015
- 04092015@82
- 6/8/2015
- 05082015@37
- 7/7/2015
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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