Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Hydromorphone 60 mg/ml + Fentanyl 1 Recalled by The Compounding Pharmacy of America Due to Lack of Assurance of Sterility; FDA inspection identified...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact The Compounding Pharmacy of America directly.
Affected Products
Hydromorphone 60 mg/ml + Fentanyl 1,000 mcg/ml + Bupivacaine 10 mg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
Quantity: 45 ml
Why Was This Recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About The Compounding Pharmacy of America
The Compounding Pharmacy of America has 383 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report