Methotrexate Sodium tablets recalled due to illegible markings and unsmooth surface
West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because some tablets have unsmooth surfaces and illegible identification markings. The recall affects 2,673 cartons distributed to MS and OH.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recalls are typically scored 1 or 2 per the rubric. The defect involves cosmetic surface irregularities and illegible identification marks, which constitute documentation and quality control failures rather than active hazards.
Plain-English summary
West-Ward Columbus Inc is recalling Methotrexate Sodium 2.5 mg tablets because tablets failed quality specifications. During inspection, unsmooth surfaces were observed on tablets, and two tablets demonstrated illegible identification and scoring. The recall affects 2,673 cartons distributed to MS and OH. The affected product is 2.5 mg tablets in 10x10 unit-dose packaging (NDC 0054-8550-25). Three lots are involved: Lot AB7486B (exp. December 2023), Lot AB8766B (exp. April 2024), and Lot AB9484B (exp. August 2024).
The manufacturing defect prevents proper tablet identification. Because Methotrexate is a prescription medication requiring accurate patient identification for correct dosing, this defect poses a potential risk.
Patients who have received tablets from the affected lots should contact their pharmacy or healthcare provider. The FDA has classified this as a Class III recall. For more information, consumers may contact West-Ward Pharmaceuticals Corp., Eatontown, NJ.
The recalled product
- Product
- METHOTREXATE SODIUM (METHOTREXATE SODIUM)
- Brand
- METHOTREXATE SODIUM
- Manufacturer
- West-Ward Columbus Inc
- Category
- Drug
- Hazard
- manufacturing-defect
- illegible-markings
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- Lot
- expiry: Lot AB7486B
- exp Dec 2023
- Lot AB8766B
- exp April 2024
- Lot AB9484B
- exp Aug 2024
UPCs (1)
- 0300544550253
Distribution
Distributed in 2 states:
- MS
- OH
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