Cephalexin for Oral Suspension USP 250mg/5 mL recall: CGMP Deviations
Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin…
Why was Cephalexin for Oral Suspension USP 250mg/5 mL recalled?
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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
lot F801282, Expiry June 2020
- Product
- Cephalexin for Oral Suspension USP 250mg/5 mL, Rx Only Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin…
- Recalling firm
- Lupin Pharmaceuticals Inc.
- 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.
- Recall date
- February 6, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)