Gentamicin recall: Sterility Concern
GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA…
Why was Gentamicin recalled?
Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
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 compounded between 11-Sep-15 and 17-Sep-15. Expiries: a) 30-Sep-15, b) 25-Sep-15, c) 24-Sep-15
- Product
- GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps, and c) 375MG in a 75ML Homepumps, Rx Only. SENTARA HOME HEALTH SENTARA…
- Recalling firm
- Sentara Enterprises
- Quantity
- a) 11 bags, b) 9 Bags, c) 3 Bags
- Distribution
- U.S. Including: VA, NC
- Recall date
- February 3, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)