Recalls / Class III
Class IIID-0304-2020
Product
Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
- Affected lot / code info
- Lot #: F802436, F802437, F802438, F802442, Exp 11/20
Why it was recalled
Presence of Foreign substance: identified as a dead ant.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- Harborplace Tower, 111 S Calvert St Fl 21st, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 28,254 bottles
- Distribution pattern
- Product was distributed to major distributors/wholesalers throughout the United States.
Timeline
- Recall initiated
- 2019-11-01
- FDA classified
- 2019-11-07
- Posted by FDA
- 2019-11-13
- Terminated
- 2021-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0304-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.