FDA Recalls Morphine and Clonidine Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Morphine and Clonidine solution nationwide 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. According to the rubric, FDA Class II recalls involving significant quality issues like sterility assurance in injectable drugs are categorized as Severe.
Plain-English summary
The Compounding Pharmacy of America is recalling Morphine 50 mg/ml + Clonidine 200 mcg/ml Solution, Sterile-Preservative Free. The recall covers 129 ml total volume units distributed nationwide between November 2014 and May 2015. Specific lot codes include 03222015@23, 04072015@68, and 04142015@76.
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.
Healthcare providers and patients should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. The source text does not report any specific illnesses or injuries associated with this recall.
The recalled product
- Product
- Morphine 50 mg/ml + Clonidine 200 mcg/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 (7)
- All lots distributed between November 2014 and May 2015
- 03222015@23
- 5/31/2015
- 04072015@68
- 7/6/2015
- 04142015@76
- 7/13/2015
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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