Drug product
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited Mandideep 462 046 India --- NDC 68180-441-01
D-0423-2019
Product summary
- Event
- Event 81908
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,400 bottles
- Official record key
drug-enforcement:D-0423-2019
Official wording
Reason: CGMP Deviations; presence of extraneous material in the was observed in area that is between the primary package that is heat sealed and secondary packaging (poly-woven bag) of sucrose (an excipient) used in the finished product.
Code information: lot F801282, Expiry June 2020
Distribution pattern: Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
Derived failure modes
-
Foreign material or chemical contamination
extraneous material
-
Manufacturing or process control
CGMP Deviations