Why it was recalled
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
Product description
Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
Lot numbers, UPCs & expiration codes
Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
Where it was sold
Distributed Nationwide in the USA
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-0185-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 23, 2020
- FDA report date
- Jan 13, 2021
- Quantity
- 20,232 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0185-2021, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 86850
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot#: a) 19144340, 19144341, Exp AUG 2021; b) 20142226, 20142227, Exp MAY 2022
- Postal code
- 07054-3707
- Report date
- Jan 13, 2021
- Product type
- Drugs
- Recall number
- D-0185-2021
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 20,232 bottles
- Termination date
- Jun 1, 2023
- Reason for recall
- Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, packaged as a) 100 ml (when mixed) bottle, NDC 67877-544-88; b) 200 ml (when mixed) bottle NDC 67877-544-68, Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA. Distributed by: Ascend Lab,oratories, LLC Parsippany, NJ 07054
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Nov 23, 2020
- Initial firm notification
- Center classification date
- Jan 4, 2021