Recalls / Class II
Class IID-0380-2019
Product
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
- Affected lot / code info
- lot # F602820, Expiry December 2019
Why it was recalled
CGMP Deviation; manufacturing batch record could not be located
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 7,215 bottles
- Distribution pattern
- Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-01-07
- FDA classified
- 2019-01-16
- Posted by FDA
- 2019-01-23
- Terminated
- 2020-07-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0380-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.