Recalls / Class II
Class IID-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
- Brand name
- Cephalexin
- Generic name
- Cephalexin
- Active ingredient
- Cephalexin
- Route
- Oral
- NDCs
- 68180-440, 68180-123, 68180-124, 68180-441
- FDA application
- ANDA065234
- Affected lot / code info
- lot F801282, Expiry June 2020
Why it was 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.
Recalling firm
- Firm
- Lupin Pharmaceuticals Inc.
- Manufacturer
- Lupin Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 111 S Calvert St Fl 21ST, N/A, Baltimore, Maryland 21202-6174
Distribution
- Quantity
- 14,400 bottles
- Distribution pattern
- Product was distributed to 5 wholesalers, 2 drug chains and 1 supermarket who may have further distributed the product throughout the United States.
Timeline
- Recall initiated
- 2019-01-09
- FDA classified
- 2019-01-31
- Posted by FDA
- 2019-02-06
- Terminated
- 2020-04-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0423-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.