Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution due to FDA inspection findings regarding GMP violations and lack of sterility assurance.
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 medication where GMP violations impact sterility assurance, fitting the criteria for significant injury risk or structural defect in a high-risk product context.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide in 22 ml quantities. All lots distributed between November 2014 and May 2015 are affected, including lot 03202015@85 with an expiration date of 6/18/2015.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, resulting in a lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on return or disposal. This recall involves a sterile injectable solution, and the potential lack of sterility poses a risk to patients.
The recalled product
- Product
- Hydromorphone 70 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable Solution
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
- 03202015@85
- 6/18/2015
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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