FDA Recall D-0066-2024

West-Ward Columbus Inc · Columbus, OH

Class III Ongoing 965 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024

Quantity: 2,673 cartons

Reason for recall

Failed Tablet/Capsule Specifications: Tablets were observed to have an unsmooth surface with two tablets demonstrating illegible tablet identification and scoring.

Recall record

Recall number: D-0066-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: MS, OH
Recall initiated: 2023-09-22
Classified by FDA Center: 2023-10-23
FDA published: 2023-11-01
Recalling firm: West-Ward Columbus Inc
Firm location: Columbus, OH

Drug identification

Brand name(s): METHOTREXATE SODIUM
Generic name(s): METHOTREXATE SODIUM
Manufacturer(s): Hikma Pharmaceuticals USA Inc.
NDC(s): 0054-4550, 0054-8550
Route(s): ORAL

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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