Hydromorphone and Bupivacaine Solution Recalled for Sterility Assurance Concerns
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine solution due to FDA inspection findings of GMP violations that may impact 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall is mapped to a score of 4 (Severe).
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 40 mg/ml + Bupivacaine 20 mg/ml Solution, Sterile-Preservative Free. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected product is a 45 ml sterile, preservative-free solution. The recall covers all lots distributed between November 2014 and May 2015, specifically lot 03162015@64 (expiration date 6/14/2015) and lot 04162015@53 (expiration date 7/15/2015). The product was distributed nationwide.
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, or where the probability of serious adverse health consequences is remote.
The recalled product
- Product
- Hydromorphone 40 mg/ml + Bupivacaine 20 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@64
- 6/14/2015
- 04162015@53
- 7/15/2015
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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