FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling Hydromorphone, Clonidine, and Baclofen intrathecal solution because FDA inspections found GMP violations that may have compromised sterility.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 intrathecal product where sterility assurance was compromised, posing a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling 86 ml vials of Hydromorphone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution. The recall was initiated after the FDA identified Good Manufacturing Practice (GMP) violations during an inspection that potentially impacted the product's quality and sterility.
The affected product was distributed nationwide between November 2014 and May 2015. Specific lot codes include 04142015@68 (dated 7/13/2015) and 03162015@67 (dated 5/20/2015). The product is a sterile, preservative-free solution intended for intrathecal administration.
Patients who have received this medication should contact their healthcare provider for further instructions. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.
The recalled product
- Product
- Hydromophone 10 mg/ml + Clonidine 300 mcg/ml + Baclofen 120 mcg/ml Intrathecal Solution, Sterile-reservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
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 04142015@68
- 7/13/2015
- 03162015@67
- 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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