Morphine and Clonidine Solution Recalled for Sterility Assurance Issues
The Compounding Pharmacy of America is recalling Morphine and Clonidine 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. Per the rubric, FDA Class II recalls involving significant risks such as sterility assurance failures in injectable medications are categorized as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 40 mg/ml + Clonidine 500 mcg/ml Solution, Sterile-Preservative Free. The product is a 45 ml total volume solution distributed nationwide. The recall covers all lots distributed between November 2014 and May 2015, specifically including lot 05042015@3 (dated 8/2/2015) and lot 03122015@101 (dated 5/20/2015).
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, resulting in a lack of assurance of sterility.
Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their healthcare provider for instructions on return or disposal.
The recalled product
- Product
- Morphine 40 mg/ml + Clonidine 500 mcg/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
- 05042015@3
- 8/2/2015
- 03122015@101
- 5/20/2015
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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