Hydromorphone 60 mg/ml + Fentanyl 7 recall: Sterility Concern
Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution…
Why was Hydromorphone 60 mg/ml + Fentanyl 7 recalled?
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All lots distributed between November 2014 and May 2015; 03022015@7, 5/31/2015; 03202015@59, 6/18/2015; 04172015@39, 6/16/2015
- Product
- Hydromorphone 60 mg/ml + Fentanyl 7,500 mcg/ml + Bupivacaine 30 mg/ml + Clonidine 1,100 mcg/ml + Baclofen 600 mcg/ml Intrathecal Solution…
- Recalling firm
- The Compounding Pharmacy of America
- Quantity
- 67 ml
- Distribution
- Nationwide
- Recall date
- September 23, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)