Drug Enforcement D-0066-2024

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

Status

Ongoing

Classification

Class III

Report Date

November 1, 2023

Termination Date

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Product Information

Product description
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
Product 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 initiation reason
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Initial firm notification
Letter
Distribution pattern
MS, OH

Location & Firm

Recalling firm
West-Ward Columbus Inc
Address
1809 Wilson Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
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Codes & Dates

Recall number
D-0066-2024
Event ID
93223
Recall initiation date
September 22, 2023
Center classification date
October 23, 2023
Code info
Lot, expiry: Lot AB7486B, exp Dec 2023; Lot AB8766B, exp April 2024; Lot AB9484B, exp Aug 2024
More code info
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