Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0173-2021·Announced 2020-12-09

Ascend Recalls Tizanidine Tablets for Failed Dissolution Specifications

Ascend Laboratories LLC is recalling 1,200 bottles of Tizanidine 4mg tablets distributed in Michigan due to failed dissolution specifications.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which is a reasonable probability of temporary or medically reversible adverse health consequences. The hazard is a quality control failure (dissolution) without reported injuries or illnesses, fitting the Moderate category for low-risk contamination or voluntary precautionary recalls.

Plain-English summary

Ascend Laboratories LLC is recalling 1,200 bottles of Tizanidine Tablets, USP 4mg, NDC 67877-614-15. The affected product is identified by Lot #19143017 and has an expiration date of 05/31/2021. The tablets were manufactured by Alkem Laboratories Ltd in India and distributed by Ascend Laboratories LLC in Parsippany, NJ.

The recall was initiated because the product failed dissolution specifications, resulting in out-of-specification (low) results. This means the tablets may not dissolve at the rate required by the United States Pharmacopeia, potentially affecting the drug's performance.

The affected product was distributed in Michigan. Consumers who have this specific lot of Tizanidine should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative medication.

The recalled product

Product: TIZANIDINE (TIZANIDINE)
Brand: TIZANIDINE
Manufacturer: Ascend Laboratories LLC
Category: Drug — Prescription Drug
Hazard: failed-dissolution
Affected units: 1,200

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 #19143017
Exp. 05/31/2021

Distribution

Distributed in 1 state:

Same brand · TIZANIDINE

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