FDA Recalls Morphine, Clonidine, and Baclofen Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile morphine, clonidine, and baclofen 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 and involves a sterile injectable solution where GMP violations impact sterility, posing a risk of serious infection or injury, which aligns with the 'Severe' criteria for significant injury risk or Class II with potential for hospitalization.
Plain-English summary
The Compounding Pharmacy of America is recalling 44 ml vials of Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 mcg/ml Solution, Sterile, Preservative Free. The recall was initiated after FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 03092015@25 (dated 6/7/2015) and 04242015@44 (dated 7/23/2015). The product is a sterile, preservative-free solution intended for medical use.
Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product may cause temporary or medically reversible health consequences.
The recalled product
- Product
- Morphine 50 mg/ml + Clonidine 750 mcg/ml + Baclofen 15 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 (5)
- All lots distributed between November 2014 and May 2015
- 03092015@25
- 6/7/2015
- 04242015@44
- 7/23/2015
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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