FDA Recalls Morphine and Bupivacaine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Bupivacaine solution nationwide due to FDA inspection findings regarding sterility assurance.
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 (4) under the rubric, particularly given the risk of sterility failure in an injectable drug.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 70 mg/ml + Bupivacaine 40 mg/ml Solution, Sterile-Preservative Free. The product is a 44 ml total volume solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically identified by the codes 03222015@80 (expiration 5/31/2015) and 03202015@77 (expiration 6/18/2015).
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact product quality and sterility. The agency cited a lack of assurance of sterility as the primary reason for the action.
Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on how to return or dispose of the medication.
The recalled product
- Product
- Morphine 70 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 (4)
- All lots distributed between November 2014 and May 2015 03222015@80
- 5/31/2015
- 03202015@77
- 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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