D-0380-2019 Class II Terminated
FDA drug recall D-0380-2019 was initiated by Lupin Pharmaceuticals Inc. on January 7, 2019 and is designated Class II. Reason for recall: CGMP Deviation; manufacturing batch record could not be located The recall status is terminated (terminated July 8, 2020). Affected quantity: 7,215 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- January 23, 2019
- Initiation Date
- January 7, 2019
- Termination Date
- July 8, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,215 bottles
Product Description
Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
Reason for Recall
CGMP Deviation; manufacturing batch record could not be located
Distribution Pattern
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Code Information
lot # F602820, Expiry December 2019