Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution due to FDA inspection findings of GMP violations that may impact sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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, posing a significant risk of infection or harm.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 30 mg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide in 44 ml quantities. The recall involves lots distributed between November 2014 and May 2015, specifically lot 03122015@93 (expiration 6/10/2015) and lot 04242015@46 (expiration 7/23/2015).
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, creating a lack of assurance of sterility. The agency has classified this recall as Class II.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. No specific illnesses or injuries are reported in the source text.
The recalled product
- Product
- Hydromorphone 30 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 (5)
- All lots distributed between November 2014 and May 2015
- 03122015@93
- 6/10/2015
- 04242015@46
- 7/23/2015
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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