FDA Recalls Hydromorphone Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 0.25 mg/ml Intrathecal 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 and involves a sterile intrathecal drug 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 0.25 mg/ml Intrathecal Solution, Sterile-Preservative Free. The recall involves 86 ml total of the product, which was distributed nationwide between November 2014 and May 2015. Specific lots include 04092015@64 (dated 7/8/2015) and 04032015@28 (dated 7/2/2015).
The recall was initiated 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 agency has classified this recall as Class II.
Patients and healthcare providers should stop using the affected lots of Hydromorphone 0.25 mg/ml Intrathecal Solution and contact their healthcare provider for further instructions.
The recalled product
- Product
- Hydromorphone 0.25 mg/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 (5)
- All lots distributed between November 2014 and May 2015
- 04092015@64
- 7/8/2015
- 04032015@28
- 7/2/2015
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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