FDA Recalls Compounded Hydromorphone and Fentanyl Intrathecal Solution for Sterility Concerns
The Compounding Pharmacy of America is recalling compounded intrathecal solutions 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 and involves a lack of assurance of sterility in an intrathecal (injected into the spinal canal) medication, which poses a significant risk of serious injury or infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.
The affected product is a 70 ml intrathecal solution. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates include 03022015@6 (5/31/2015), 04172015@25 (6/16/2015), and 05082015@35 (7/7/2015).
Patients who have received this medication should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Hydromorphone 80 mg/ml + Fentanyl 15,000 mcg/ml + Bupivacaine 30 mg/ml Intrathecal Solution, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
- Category
- Drug — Compounded Injectable
- 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
- 03022015@6
- 5/31/2015
- 04172015@25
- 6/16/2015
- 05082015@35
- 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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