Why it was recalled
Failed Impurities/Degradation Specificattion
Product description
Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
Lot numbers, UPCs & expiration codes
Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
Where it was sold
Nationwide USA and Puerto Rico
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-1863-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 9, 2019
- FDA report date
- Sep 25, 2019
- Quantity
- 32,347 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1863-2019, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 83698
- Address
- 1809 Wilson Rd
- Code information
- Lot, expiry: Lots AA3957A, AA3958A, exp May 2020; Lot AA5164A, exp Sep 2020
- Postal code
- 43228-9579
- Report date
- Sep 25, 2019
- Product type
- Drugs
- Recall number
- D-1863-2019
- Classification
- Class II
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 32,347 bottles
- Termination date
- Jun 15, 2022
- Reason for recall
- Failed Impurities/Degradation Specificattion
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, Distr. by: West-Ward Pharmaceuticals,Eatontown, NJ. NDC:0054-0199-59
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Sep 9, 2019
- Initial firm notification
- Letter
- Center classification date
- Sep 16, 2019