Why it was recalled
Failed Impurities/Degradation Specifications
Product description
Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
Lot numbers, UPCs & expiration codes
Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
Where it was sold
Product was distributed to two direct accounts in MI and PA.
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-0360-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 29, 2021
- FDA report date
- Jan 12, 2022
- Quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- RemedyRepack Inc.
Original FDA data
Every field from FDA enforcement report D-0360-2022, exactly as published.
Show all FDA fields
- City
- Indiana
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 89322
- Address
- 625 Kolter Dr Ste 4
- Code information
- Lot #: a) B1429436-110821, Exp 07/2022; B1429434-110821, Exp 11/2022; B1429435-110821, Exp 11/2022; B1279449-072021, Exp 07/2022; B1279457-072021, Exp 07/2022; B1279442-072021,Exp 07/2022; B1057718-012621, Exp 01/2022; B1057727-012621, Exp 01/2022; b) B1358139-092121, Exp 03/2022; B1424654-110421, B1437578-111421, Exp 05/2022
- Postal code
- 15701-3571
- Report date
- Jan 12, 2022
- Product type
- Drugs
- Recall number
- D-0360-2022
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Product quantity
- a) 716 bottles/ 1432 capsules b) 223 blister packs/ 466 capsules
- Termination date
- Apr 14, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Cefixime 400 mg capsule, packaged in a) 2-count bottle (NDC 70518-2749-02), b) 2-count blister pack (NDC 70518-2749-03), Rx only, MFG: Ascend Labs, LLC, Montvale, NJ 07645
- Distribution pattern
- Product was distributed to two direct accounts in MI and PA.
- Recall initiation date
- Dec 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 5, 2022