Drug recall D-0423-2019
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
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.
Lots and codes
lot F801282, Expiry June 2020
Recall details
- Recalling firm
- Lupin Pharmaceuticals Inc., Baltimore, MD
- Quantity
- 14,400 bottles
- Distribution
- Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
- Type
- Voluntary: Firm initiated
- Recall initiated
- January 9, 2019
- Terminated
- April 8, 2020
Related products
- Cephalexin – drug information
- NDC 68180-440 Cephalexin · Cephalexin 125 mg/5mL · Lupin Pharmaceuticals, Inc.
- NDC 68180-441 Cephalexin · Cephalexin 250 mg/5mL · Lupin Pharmaceuticals, Inc.