Stat Rx USA Recalls Tizanidine Tablets Due to Labeling Error
Stat Rx USA is recalling 51 bottles of Tizanidine 4 mg tablets because some labels incorrectly identified Actavis as the manufacturer.
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 a minor labeling error.
Plain-English summary
Stat Rx USA is recalling 51 bottles of Tizanidine 4 mg tablets (NDC 16590-221-90). The product is a prescription-only medication, manufactured by Dr Reddys Labs Ltd. and packaged and distributed by Stat Rx USA. The specific lot number is 28JN1272, with an expiration date of 02/15.
The recall was initiated due to a labeling error where some bottles had the incorrect manufacturer, Actavis, printed on the label instead of the correct manufacturer. This is a Class III recall, which indicates that the product is not likely to cause adverse health consequences.
Consumers who have this product should check their bottles for the specific lot number and expiration date. If the product matches the description, they should contact their pharmacist or healthcare provider for guidance on what to do with the medication.
The recalled product
- Product
- Tizanidine (Generic for: Zanaflex), 4 mg, 90 Tablets per Bottle, Rx only, , Mfg By: Dr Reddys Labs Ltd., Bachepally, IN 500 - 090, Packaged and distributed by STAT Rx USA, Gainesville, GA, NDC 16590-221-90.
- Manufacturer
- Stat Rx USA
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 51
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 #: 28JN1272
- Exp 02/15
Distribution
Distributed nationwide across the United States.
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