FDA Recalls Hydromorphone and Bupivacaine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone and Bupivacaine 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' rating under the rubric for significant potential health risks, such as sterility failures in injectable medications.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 40 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free. The product was distributed nationwide between November 2014 and May 2015. The recall is being conducted because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The recall involves all lots distributed during the specified period, including lot 03202015@79. The source text does not report any specific illnesses or injuries associated with the use of this product.
Consumers and healthcare providers should stop using the recalled product and contact the manufacturer or their healthcare provider for further instructions on how to return or dispose of the medication.
The recalled product
- Product
- Hydromorphone 40 mg/ml + Bupivacaine 40 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@79
- 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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