FDA Recalls Compounded Intrathecal Pain Medication Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded intrathecal pain medication because FDA inspections 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 and involves a sterile intrathecal medication where sterility assurance is compromised, posing a risk of serious infection or injury.
Plain-English summary
The Compounding Pharmacy of America is recalling a specific compounded intrathecal solution containing hydromorphone, fentanyl, bupivacaine, clonidine, and baclofen. The recall is being conducted due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 66 ml sterile, preservative-free intrathecal solution. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and dates identified in the recall include 03092015@17, 6/7/2015, 04032015@26, 7/2/2015, 5012015@15, and 7/30/2015.
Patients who have received this medication should contact their healthcare provider for guidance. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydromorphone 60 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 35 mg/ml + Clonidine 1,200 mcg/ml + Baclofen 90 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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
- 03092015@17
- 6/7/2015
- 04032015@26
- 7/2/2015
- 5012015@15
- 7/30/2015
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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