FDA Recalls Compounded Sterile Anesthesia Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a sterile, preservative-free compounded solution containing morphine, fentanyl, bupivacaine, and clonidine due to GMP violations affecting 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 and involves a sterile injectable product where GMP violations impact sterility assurance, posing a significant risk of infection or serious injury.
Plain-English summary
The Compounding Pharmacy of America is recalling 70 ml vials of a sterile, preservative-free solution containing Morphine 50 mg/ml, Fentanyl 20,000 mcg/ml, Bupivacaine 30 mg/ml, and Clonidine 1,200 mcg/ml. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 03122015@23 (expired 6/10/2015), 04092015@73 (expired 6/8/2015), and 05082015@39 (expired 7/7/2015).
Healthcare providers and patients should stop using the affected product and contact the recalling firm or their healthcare provider for further instructions. The FDA has classified this recall as 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 + Fentanyl 20,000 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,200 mcg/ml Solution, Sterile, Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- 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
- 03122015@23
- 6/10/2015
- 04092015@73
- 6/8/2015
- 05082015@39
- 7/7/2015
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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