Recalls / Class III
Class IIID-0066-2024
Product
Methotrexate Tablets, USP, 2.5 mg, 10x10 Unit-Dose Tablets per carton, Rx only, Distributed by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724. NDC: 0054-8550-25
- Brand name
- Methotrexate Sodium
- Generic name
- Methotrexate Sodium
- Active ingredient
- Methotrexate Sodium
- Route
- Oral
- NDCs
- 0054-4550, 0054-8550
- FDA application
- ANDA040054
- Affected lot / code info
- Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
Why it was recalled
Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.
Recalling firm
- Firm
- West-Ward Columbus Inc
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1809 Wilson Rd, N/A, Columbus, Ohio 43228-9579
Distribution
- Quantity
- 2,673 cartons
- Distribution pattern
- MS, OH
Timeline
- Recall initiated
- 2023-09-22
- FDA classified
- 2023-10-23
- Posted by FDA
- 2023-11-01
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0066-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.