The Recall Desk
LowFDA (Drugs)·D-0330-2021·Announced 2021-04-21

Enovachem Recalls Methylprednisolone Tablets Due to Illegible Labeling

Enovachem Pharmaceuticals is recalling Methylprednisolone Tablets due to misaligned printing on the blister card that renders dosing instructions illegible.

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, which by definition is unlikely to cause adverse health consequences, and the issue is limited to packaging/labeling legibility.

Plain-English summary

Asclemed USA Inc. dba Enovachem Pharmaceuticals is recalling Methylprednisolone Tablets, USP 4 mg, 21 Count Blister (NDC: 69306-004-21). The recall was initiated after the manufacturer received a complaint regarding misaligned printing of the dosing instructions on the blister card, which resulted in an illegible label.

The affected product was distributed to three physicians in California and Louisiana by Enovachem. Additionally, DocRx distributed the recalled product to one distributor located in Alabama. The specific lots involved are 20K0043P (expiration 8/31/2022) and 20L0026P (expiration 9/30/2022).

Consumers and healthcare providers should stop using the affected product and contact the recalling firm for further instructions. This recall is classified as Class III by the FDA, indicating that the product is not likely to cause adverse health consequences.

The recalled product

Product
Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Blister, NDC: 69306-004-21, Relabeled by: Enovachem Pharmaceuticals 379 Van Ness Ave. Suite 1403-1406, Torrance, CA 90501, Manufactured by: Jubilant Cadista Pharmaceuticals Inc. Source NDC: 59746-001-03, Do

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 (4)

  • Lot #: 20K0043P
  • Exp. 8/31/2022
  • 20L0026P
  • Exp. 9/30/2022

Distribution

Distributed in 3 states:

Same manufacturer · Asclemed USA Inc. dba Enovachem Pharmaceuticals

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