Drug product
Levofloxacin Tablets, 500 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-6352-61
D-1088-2022
Product summary
- Event
- Event 89646
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 box/100 blisters packs per box
- Official record key
drug-enforcement:D-1088-2022
Official wording
Reason: cGMP deviations: Temperature abuse
Code information: 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.
Distribution pattern: USA nationwide.
Derived failure modes
-
Manufacturing or process control
cGMP deviations