D-0423-2019 Class II Terminated
FDA drug recall D-0423-2019 was initiated by Lupin Pharmaceuticals Inc. on January 9, 2019 and is designated Class II. Reason for recall: 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)… The recall status is terminated (terminated April 8, 2020). Affected quantity: 14,400 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- February 6, 2019
- Initiation Date
- January 9, 2019
- Termination Date
- April 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,400 bottles
Product Description
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
Reason for Recall
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.
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.
Code Information
lot F801282, Expiry June 2020