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.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
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…
- Manufacturer
- Asclemed USA Inc. dba Enovachem Pharmaceuticals
- Category
- Drug — Prescription Medication
- Hazard
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
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