Morphine and Bupivacaine Solution Recalled for Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine 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 recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 42 mg/ml + Bupivacaine 8 mg/ml Solution, Sterile-Preservative Free. The product is a 44 ml total volume solution manufactured in Knoxville, Tennessee.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns regarding the assurance of sterility and potentially impact the overall quality of the product.
The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes include 03122015@4 (expiration 6/10/2015) and 05012015@22 (expiration 7/30/2015). The product was distributed nationwide. Consumers and healthcare providers should stop using the product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Morphine 42 mg/ml + Bupivacaine 8 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
- 03122015@4
- 6/10/2015
- 05012015@22
- 7/30/2015
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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