The Recall Desk
LowFDA (Drugs)·D-1490-2020·Announced 2020-08-19

West-Ward Recalls Leucovorin Calcium Tablets With Incorrect Identification Code

West-Ward Columbus Inc. is recalling 2,300 bottles of Leucovorin Calcium 10 mg tablets because they are imprinted with the incorrect identification code.

What this means for you

Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.

Our severity reasoning: The recall is classified as FDA Class III, and the hazard is a documentation/labeling issue (incorrect identification code) rather than a physical or chemical defect that poses a direct health risk.

Plain-English summary

West-Ward Columbus Inc. is recalling 2,300 bottles of Leucovorin Calcium Tablets USP, 10 mg. The product is distributed by West-Ward Pharmaceuticals Corp. and is identified by NDC 0054-4497-10. The specific lot affected is #064046A, with an expiration date of 03/2022.

The recall was initiated because the tablets are imprinted with the incorrect identification code. This is a Class III recall, which the FDA defines as a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.

The affected product was distributed in Ohio (OH) and Mississippi (MS). Consumers who have this specific lot of Leucovorin Calcium should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product
LEUCOVORIN CALCIUM (LEUCOVORIN CALCIUM)
Brand
LEUCOVORIN CALCIUM
Affected units
2,300

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 (2)

  • Lot: #064046A
  • Exp. 03/2022

UPCs (3)

  • 0300544498104
  • 0300544499118
  • 0300544497053

Distribution

Distributed in 2 states: