FDAFDA · Food and drugs·Recall number D-0995-2022
TobraDex (tobramycin and dexamethasone), Ophthalmic Ointment, 3.5 gm, Rx only, Manufacturer: Novartis, NDC 0078-0876-01
Published June 15, 2022 · Recall initiated: April 13, 2022
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP deviations: Temperature abuse
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- TOBRADEX
- Manufacturer
- Mckesson Medical-Surgical Inc. Corporate Office
- Distributor
- USA nationwide.
- Lot
- McKesson Medical-Surgical (MMS) is not able to identify the particular lot number received by a particular consignee for the recalled prescription products. Each letter includes the date it was distributed to customers and the dates that impacted product may have been shipped to the customer. The letters clearly explain that consignees should identify product received from MMS between June 1 and September 30, 2021. A consignee should be able to use its own records to determine whether it received an impacted product from MMS during that timeframe and whether it still has any of that product in inventory. The recall notification letter informs consignees that they may contact Sedgwick if they have any questions.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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