FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 1 mg/ml 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 and involves a sterile injectable product where sterility assurance is compromised, posing a significant risk of serious injury or death from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 1 mg/ml Intrathecal Solution, Sterile-Preservative Free. The recall involves 22 ml vials distributed nationwide between November 2014 and May 2015. Specific lot codes include 04272015@22, with a date of 7/26/2015.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, meaning there is a lack of assurance that the solution is sterile.
Patients and healthcare providers who have received this product should contact their healthcare provider for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- Hydromorphone 1 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 (3)
- All lots distributed between November 2014 and May 2015
- 04272015@22
- 7/26/2015
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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