Why it was recalled
CGMP Deviation; manufacturing batch record could not be located
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
Lot numbers, UPCs & expiration codes
lot # F602820, Expiry December 2019
Where it was sold
Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0380-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 7, 2019
- FDA report date
- Jan 23, 2019
- Quantity
- 7,215 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Lupin Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-0380-2019, exactly as published.
Show all FDA fields
- City
- Baltimore
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 81898
- Address
- 111 S Calvert St Fl 21ST
- Code information
- lot # F602820, Expiry December 2019
- Postal code
- 21202-6174
- Report date
- Jan 23, 2019
- Product type
- Drugs
- Recall number
- D-0380-2019
- Classification
- Class II
- Recalling firm
- Lupin Pharmaceuticals Inc.
- Product quantity
- 7,215 bottles
- Termination date
- Jul 8, 2020
- Reason for recall
- CGMP Deviation; manufacturing batch record could not be located
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed to 12 major distributors who may have further distributed the product throughout the United States.
- Recall initiation date
- Jan 7, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 16, 2019