Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 5 mg/ml 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, which corresponds to a 'Severe' severity score under the rubric for drug recalls involving potential sterility issues.
Plain-English summary
The Compounding Pharmacy of America is recalling 87 ml of Hydromorphone 5 mg/ml Solution, Sterile-Preservative Free. The recall covers all lots distributed nationwide between November 2014 and May 2015.
The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product. There is a lack of assurance that the product is sterile.
Consumers and healthcare providers should stop using the recalled product and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Hydromorphone 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 (7)
- All lots distributed between November 2014 and May 2015
- 03022015@10
- 5/31/2015
- 04132015@4
- 6/12/2015
- 04222015@1
- 6/21/2015
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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