FDA Recalls Hydromorphone and Baclofen Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone and Baclofen Intrathecal Solution 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. According to the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are Severe. While specific injury reports are not detailed in the snippet, the potential for sterility failure in an intrathecal drug is a significant health risk consistent with the Severe classification for Class II recalls with potential for serious harm.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The product is a 23 ml total volume solution. The recall covers all lots distributed between November 2014 and May 2015, including lot 04142015@74 dated 7/13/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The lack of assurance of sterility is the primary reason for the action. The product was distributed nationwide.
Patients and healthcare providers should stop using the recalled product and contact their healthcare provider for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Hydromorphone 10 mg/ml + Baclofen 2,500 mcg/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
- 04142015@74
- 7/13/2015
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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