Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 12.5 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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the lack of sterility assurance in a sterile injectable solution represents a significant risk of harm, aligning with the Severe criteria for high-risk products where injury has not yet been reported but the hazard is significant.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 12.5 mg/ml Solution, Sterile-Preservative Free. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility.
The affected product is distributed nationwide. The recall includes all lots distributed between November 2014 and May 2015, specifically lot 03162015@50 with an expiration date of 6/14/2015 and lot 04142015@81 with an expiration date of 7/13/2015. The total quantity involved is 86 ml.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The FDA classifies 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 12.5 mg/ml Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Injectable 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
- 03162015@50
- 6/14/2015
- 04142015@81
- 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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