Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Product description
Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
Lot numbers, UPCs & expiration codes
Lot #: AA4424A, Exp. 07/31/2020
Where it was sold
Nationwide in the US
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-1282-2020
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- May 13, 2020
- FDA report date
- May 27, 2020
- Quantity
- 3336 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- West-Ward Columbus Inc
Original FDA data
Every field from FDA enforcement report D-1282-2020, exactly as published.
Show all FDA fields
- City
- Columbus
- State
- OH
- Status
- Terminated
- Country
- United States
- Event ID
- 85709
- Address
- 1809 Wilson Rd
- Code information
- Lot #: AA4424A, Exp. 07/31/2020
- Postal code
- 43228-9579
- Report date
- May 27, 2020
- Product type
- Drugs
- Recall number
- D-1282-2020
- Classification
- Class III
- Recalling firm
- West-Ward Columbus Inc
- Product quantity
- 3336 Bottles
- Termination date
- Oct 2, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.
- Distribution pattern
- Nationwide in the US
- Recall initiation date
- May 13, 2020
- Initial firm notification
- Letter
- Center classification date
- May 29, 2020