Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
Lot numbers, UPCs & expiration codes
Lot 20140282, exp Dec 2021
Where it was sold
Nationwide
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-0229-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 3, 2021
- FDA report date
- Nov 17, 2021
- Quantity
- 4104 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0229-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88982
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot 20140282, exp Dec 2021
- Postal code
- 07054-3707
- Report date
- Nov 17, 2021
- Product type
- Drugs
- Recall number
- D-0229-2022
- Classification
- Class II
- Recalling firm
- Ascend Laboratories LLC
- Product quantity
- 4104 bottles
- Termination date
- Dec 21, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime Capsules 400 mg, 50 capsules bottles, Rx Only, Manufactured by: Alken Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories LLC, Parsippany, NJ, 07054 NDC 67877-584-50
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 3, 2021
- Initial firm notification
- Letter
- Center classification date
- Nov 9, 2021